Carl H Backes1, Kevin F Kennedy2, Megan Locke3, Clifford L Cua4, Molly K Ball5, Tyler A Fick5, Brian K Rivera3, Charles V Smith6, Ralf J Holzer7, Brian A Boe4, Darren P Berman4, Lisa Bergersen8, Aimee K Armstrong4. 1. Center for Perinatal Research, Nationwide Children's Hospital, Columbus, Ohio; Center for Cardiovascular and Pulmonary Research, Nationwide Children's Hospital, Columbus, Ohio; The Heart Center, Nationwide Children's Hospital, Columbus, Ohio; Department of Pediatrics at Nationwide Children's Hospital, Columbus, Ohio. Electronic address: Carl.BackesJr@nationwidechildrens.org. 2. Mid-America Heart Institute, Kansas City, Missouri. 3. Center for Perinatal Research, Nationwide Children's Hospital, Columbus, Ohio. 4. Center for Cardiovascular and Pulmonary Research, Nationwide Children's Hospital, Columbus, Ohio; The Heart Center, Nationwide Children's Hospital, Columbus, Ohio; Department of Pediatrics at Nationwide Children's Hospital, Columbus, Ohio. 5. Department of Pediatrics at Nationwide Children's Hospital, Columbus, Ohio. 6. Seattle Children's Research Institute, Center for Developmental Therapeutics, Seattle, Washington. 7. Weill Cornell Medical College, Department of Pediatrics, New York, New York; Cardiac Catheterization and Interventional Therapy, Sidra Cardiac Program, Sidra Medical and Research Center, Doha, Qatar. 8. Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: The authors sought to identify risk factors associated with major adverse events (MAEs) in infants <6 kg undergoing transcatheter patent ductus arteriosus (PDA) occlusion. BACKGROUND: Transcatheter PDA occlusion is among the safest of interventional cardiac procedures in adults and older children, but use among infants <6 kg has not been characterized adequately. METHODS: Using the IMPACT (IMproving Pediatric and Adult Congenital Treatments) registry, we identified infants <6 kg undergoing transcatheter PDA occlusion (January 1, 2011, to March 1, 2015). Using mixed-effects multivariate regression, the authors assessed characteristics predictive of MAE or composite failure (procedural failure or MAE). Individual safety metrics (e.g., embolization, malposition) were also examined for differences across weight thresholds: extremely low weight (LW) (<2 kg), very LW (2 to <4 kg), and LW (4 to <6 kg). RESULTS: Transcatheter PDA occlusion was attempted in 747 infants <6 kg at 73 hospitals. Rate of procedural success was 94.3%. MAEs were observed in 12.6% of cases; the most common events were acute arterial injury and device embolization in 3.5% and 2.4% of cases, respectively. Younger age (<30 days) was associated with greater risk of a MAE (risk ratio: 3.3; 95% confidence interval: 1.5 to 7.6) and composite failure (risk ratio: 3.0; 95% confidence interval: 1.4 to 6.7). Risk of embolization was higher among extremely LW (10.5%) than very LW or LW infants (1.6% and 2.5%, respectively; p = 0.050). CONCLUSIONS: Among infants <6 kg, transcatheter PDA occlusion is technically feasible, but risks of MAE are noteworthy. These findings may help inform patient selection and procedural approach for transcatheter PDA occlusion and direct targeted research efforts to support the practice of evidence-based medicine.
OBJECTIVES: The authors sought to identify risk factors associated with major adverse events (MAEs) in infants <6 kg undergoing transcatheter patent ductus arteriosus (PDA) occlusion. BACKGROUND: Transcatheter PDA occlusion is among the safest of interventional cardiac procedures in adults and older children, but use among infants <6 kg has not been characterized adequately. METHODS: Using the IMPACT (IMproving Pediatric and Adult Congenital Treatments) registry, we identified infants <6 kg undergoing transcatheter PDA occlusion (January 1, 2011, to March 1, 2015). Using mixed-effects multivariate regression, the authors assessed characteristics predictive of MAE or composite failure (procedural failure or MAE). Individual safety metrics (e.g., embolization, malposition) were also examined for differences across weight thresholds: extremely low weight (LW) (<2 kg), very LW (2 to <4 kg), and LW (4 to <6 kg). RESULTS: Transcatheter PDA occlusion was attempted in 747 infants <6 kg at 73 hospitals. Rate of procedural success was 94.3%. MAEs were observed in 12.6% of cases; the most common events were acute arterial injury and device embolization in 3.5% and 2.4% of cases, respectively. Younger age (<30 days) was associated with greater risk of a MAE (risk ratio: 3.3; 95% confidence interval: 1.5 to 7.6) and composite failure (risk ratio: 3.0; 95% confidence interval: 1.4 to 6.7). Risk of embolization was higher among extremely LW (10.5%) than very LW or LW infants (1.6% and 2.5%, respectively; p = 0.050). CONCLUSIONS: Among infants <6 kg, transcatheter PDA occlusion is technically feasible, but risks of MAE are noteworthy. These findings may help inform patient selection and procedural approach for transcatheter PDA occlusion and direct targeted research efforts to support the practice of evidence-based medicine.
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