Author + information
- Received March 6, 2017
- Revision received April 17, 2017
- Accepted May 4, 2017
- Published online September 4, 2017.
- Carl H. Backes, MDa,b,c,d,∗ (, )
- Kevin F. Kennedy, MSe,
- Megan Locke, BSa,
- Clifford L. Cua, MDb,c,d,
- Molly K. Ball, MDd,
- Tyler A. Fick, MDd,
- Brian K. Rivera, MSa,
- Charles V. Smith, PhDf,
- Ralf J. Holzer, MDg,h,
- Brian A. Boe, MDb,c,d,
- Darren P. Berman, MDb,c,d,
- Lisa Bergersen, MD, MPHi and
- Aimee K. Armstrong, MDb,c,d
- aCenter for Perinatal Research, Nationwide Children’s Hospital, Columbus, Ohio
- bCenter for Cardiovascular and Pulmonary Research, Nationwide Children’s Hospital, Columbus, Ohio
- cThe Heart Center, Nationwide Children’s Hospital, Columbus, Ohio
- dDepartment of Pediatrics at Nationwide Children’s Hospital, Columbus, Ohio
- eMid-America Heart Institute, Kansas City, Missouri
- fSeattle Children’s Research Institute, Center for Developmental Therapeutics, Seattle, Washington
- gWeill Cornell Medical College, Department of Pediatrics, New York, New York
- hCardiac Catheterization and Interventional Therapy, Sidra Cardiac Program, Sidra Medical and Research Center, Doha, Qatar
- iDepartment of Cardiology, Boston Children’s Hospital, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Carl H. Backes, Center for Perinatal Research and the Heart Center, Nationwide Children's Hospital, 700 Children's Drive, Columbus, Ohio 43205.
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.
Dr. Bergersen is a consultant for 480 Biomedical. Dr. Armstrong has received a research grant from PFM Medical; has been a consultant for Abbott; and has been a proctor for Abbott and B. Braun Interventional Systems. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Clinical Trial Registration: registered prospectively with the National Cardiovascular Data Registry (NCDR).
- Received March 6, 2017.
- Revision received April 17, 2017.
- Accepted May 4, 2017.
- 2017 American College of Cardiology Foundation