title: Feasibility and Safety of Using a Fused Echocardiography/Fluoroscopy Imaging System in Patients with Congenital Heart Disease.
abstract: Fused real-time three-dimensional transesophageal echocardiography and fluoroscopy has been used in adult patients during percutaneous mitral valve and aortic valve procedures. The use of fused echocardiographic/x-ray fluoroscopic imaging (FEX) in pediatric patients undergoing congenital heart disease catheterization has not been evaluated for feasibility and safety. The aims of this study were to assess the feasibility and safety of FEX for interventional guidance and to perform a comparison of atrial septal defect (ASD) device closure using this technology with traditional guidance methods.
  
  
  
  Prospective evaluation of FEX in congenital cardiac interventions was conducted. A subset of patients with ASD closures were compared with patients with historical ASD closures with and without FEX. The interventionalist and echocardiographer rated the anatomic quality of the fusion imaging as (1) excellent, (2) good, or (3) poor. In addition, the utility of FEX procedural guidance was graded as (1) superior, (2) no added benefit, or (3) inferior to that of standard guidance by fluoroscopy and transesophageal echocardiography.
  
  
  
  FEX was successfully used in 26 procedures on 25 patients with congenital heart disease from January 2013 to February 2015. The median age was 9 years (range, 3-26 years), and the median weight was 29 kg (range, 16-77 kg). Twenty-six procedures were performed, including ASD closure, Fontan fenestration closure, and transcatheter valve placement in the tricuspid valve position. There was reduced fluoroscopy time and radiation dose in patients with ASDs who underwent imaging using this new technology (P < .001 and P < .03, respectively). There were no statistically significant differences in procedural times between the two groups. Anatomic definition was rated as excellent in 20 of 26 procedures, with the remaining six rated was good. Twenty-one of 26 procedures were graded as superior (81%), and five of 26 (19%) were graded as providing no added benefit. There were no complications in any of the procedures.
  
  
  
  In this early experience, FEX is feasible and safe in patients undergoing congenital heart disease catheterization and provides useful guidance in the majority of interventional procedures. There were relative reductions in fluoroscopy time and radiation dose with the use of FEX for ASD closure.
authors.affiliation: Pediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado. Electronic address: pei-ni.jone@childrenscolorado.org.
authors.forename: Pei-Ni
authors.initials: PN
authors.lastname: Jone
authors.affiliation: Pediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Ross
authors.affiliation: Philips Research North America, Briarcliff Manor, New York.
authors.forename: John A
authors.initials: JA
authors.lastname: Bracken
authors.affiliation: Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Mulvahill
authors.affiliation: Pediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.
authors.forename: Michael V
authors.initials: MV
authors.lastname: Di Maria
authors.affiliation: Pediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Fagan
mesh_terms: D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods; D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D019560:Echocardiography, Three-Dimensional / Q000009:adverse effects / Q000379:methods*; D017548:Echocardiography, Transesophageal / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005471:Fluoroscopy / Q000009:adverse effects / Q000379:methods*; D006330:Heart Defects, Congenital / Q000000981:diagnostic imaging* / Q000601:surgery*; D006801:Humans; D008297:Male; D064847:Multimodal Imaging / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Congenital heart disease; EchoNavigator; Fused echocardiographic/fluoroscopic imaging; Fusion; Procedural guidance; Real-time 3D echocardiography