Michael L O'Byrne1, Marisa E Millenson2, Connor B Grady3, Jing Huang4, Nicolas A Bamat5, David A Munson6, Lihai Song2, Yoav Dori3, Matthew J Gillespie3, Jonathan J Rome3, Andrew C Glatz7. 1. Division of Cardiology, The Children's Hospital of Philadelphia and Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA; Leonard Davis Institute and Center for Cardiovascular Outcomes, Quality, and Evaluative Research, University of Pennsylvania, Philadelphia, PA. Electronic address: obyrnem@email.chop.edu. 2. Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA. 3. Division of Cardiology, The Children's Hospital of Philadelphia and Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. 4. Division of Cardiology, The Children's Hospital of Philadelphia and Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. 5. Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA; Division of Neonatology, INS; Philadelphia, Philadelphia, PA. 6. Division of Neonatology, INS; Philadelphia, Philadelphia, PA. 7. Division of Cardiology, The Children's Hospital of Philadelphia and Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA.
Abstract
BACKGROUND: The risks and benefits of pharmacologic treatment and operative closure of patent ductus arteriosus (O-PDA) in premature infants remain controversial. Recent series have demonstrated the feasibility of transcatheter PDA closure (TC-PDA) in increasingly small infants. The effect of this change on practice has not been evaluated. METHODS: A multicenter observational study of infants treated in neonatal intensive care units in hospitals contributing data to the Pediatric Health Information Systems Database from January 2007 to December 2017 was performed to study trends in the propensities for (1) mechanical closure of PDA and (2) TC-PDA versus O-PDA, as well as interhospital variation in practice. RESULTS: A total of 6,214 subjects at 44 hospitals were studied (5% TC-PDA). Subject median gestational age was 25 weeks (interquartile range: 24-27 weeks). Median age at closure was 24 days (interquartile range: 14-36 days). The proportion of all neonatal intensive care unit patients undergoing either O-PDA or TC-PDA decreased (3.1% in 2007 and 0.7% in 2017, P < .001), whereas the proportion in which TC-PDA was used increased significantly (0.1% in 2007 to 29.0% in 2017). Case-mix-adjusted multivariable models similarly demonstrated increasing propensity to pursue TC-PDA (odds ratio [OR] 1.66 per year, P < .001) with acceleration of the trend after 2014 (OR 2.46 per year, P < .001) as well as significant practice variation (P < .001, median OR 4.6) across the study period. CONCLUSIONS: In the face of decreasing closure of PDA, the use of TC-PDA increased dramatically with significant practice variability. This demonstrates that there is equipoise for potential clinical trials.
BACKGROUND: The risks and benefits of pharmacologic treatment and operative closure of patent ductus arteriosus (O-PDA) in premature infants remain controversial. Recent series have demonstrated the feasibility of transcatheter PDA closure (TC-PDA) in increasingly small infants. The effect of this change on practice has not been evaluated. METHODS: A multicenter observational study of infants treated in neonatal intensive care units in hospitals contributing data to the Pediatric Health Information Systems Database from January 2007 to December 2017 was performed to study trends in the propensities for (1) mechanical closure of PDA and (2) TC-PDA versus O-PDA, as well as interhospital variation in practice. RESULTS: A total of 6,214 subjects at 44 hospitals were studied (5% TC-PDA). Subject median gestational age was 25 weeks (interquartile range: 24-27 weeks). Median age at closure was 24 days (interquartile range: 14-36 days). The proportion of all neonatal intensive care unit patients undergoing either O-PDA or TC-PDA decreased (3.1% in 2007 and 0.7% in 2017, P < .001), whereas the proportion in which TC-PDA was used increased significantly (0.1% in 2007 to 29.0% in 2017). Case-mix-adjusted multivariable models similarly demonstrated increasing propensity to pursue TC-PDA (odds ratio [OR] 1.66 per year, P < .001) with acceleration of the trend after 2014 (OR 2.46 per year, P < .001) as well as significant practice variation (P < .001, median OR 4.6) across the study period. CONCLUSIONS: In the face of decreasing closure of PDA, the use of TC-PDA increased dramatically with significant practice variability. This demonstrates that there is equipoise for potential clinical trials.
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