title: Accuracy and clinical outcomes of CT image integration with Carto-Sound compared to electro-anatomical mapping for atrial fibrillation ablation: a randomized controlled study.
abstract: BACKGROUND
  Carto-Sound integrates 2D intra-cardiac ultrasound imaging into a 3D environment to allow left atrial mapping from the right atrium without fluoroscopic assistance. We conducted an open randomized controlled study to compare procedural, clinical and accuracy parameters between CT integrated Carto-Sound and electro-anatomic mapping (EAM) for AF ablation.
  
  
  METHODS
  Sixty index AF ablation patients were randomized equally to either the Carto-Sound or EAM mapping/navigation for their procedure performed at a single institution. Procedure and X-ray times, X-ray dose, navigational accuracy and clinical success were assessed. The study was powered to the primary outcome of fluoroscopy time.
  
  
  RESULTS
  Total procedure (232 ± 60 vs 223 ± 48 min; p = 0.51), ablation (p = 0.84) and mapping times (p = 0.11) were similar in each group. In contrast, Carto-Sound reduced total X-ray time (65 ± 18 vs 51 ± 12 min; p = 0.001), via a reduction in both mapping (p<0.001) and remaining procedure X-ray time (p = 0.03). Left atrial access time (p = 0.03) was also reduced using Ultra-sound assisted 3D mapping compared to the EAM group. Carto-Sound maps demonstrated equivalent mean navigational accuracy (p>0.17) compared to EAM. Ultra-sound assisted 3D mapping did not improve single procedure drug free clinical success (EAM: 13/30 [43%] vs Carto-Sound: 15/30 [50%]) at a mean of 13 ± 5 months (p = 0.79).
  
  
  CONCLUSIONS
  In the context of long left atrial procedures with high radiation doses, reduced X-ray and left atrial access times using CT integrated Carto-Sound mapping/navigation may have implications for patients and laboratory staff, albeit at an extra financial cost and the requirement of an additional access site for a right sided catheter.
  
  
  BACKGROUND
  ACTRN12612000089831.
authors.affiliation: Centre for Heart Rhythm Disorders, The Discipline of Medicine, University of Adelaide and Cardiology Department, Royal Adelaide Hospital, Adelaide, Australia.
authors.forename: Anthony G
authors.initials: AG
authors.lastname: Brooks
authors.forename: Lauren
authors.initials: L
authors.lastname: Wilson
authors.forename: Nicholas H
authors.initials: NH
authors.lastname: Chia
authors.forename: Dennis H
authors.initials: DH
authors.lastname: Lau
authors.forename: Muayad
authors.initials: M
authors.lastname: Alasady
authors.forename: Darryl P
authors.initials: DP
authors.lastname: Leong
authors.forename: Julien
authors.initials: J
authors.lastname: Laborderie
authors.forename: Kurt C
authors.initials: KC
authors.lastname: Roberts-Thomson
authors.forename: Glenn D
authors.initials: GD
authors.lastname: Young
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Kalman
authors.forename: Prashanthan
authors.initials: P
authors.lastname: Sanders
mesh_terms: D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000601:surgery*; D057791:Cardiac Imaging Techniques; D017115:Catheter Ablation; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
keywords: 3 dimensional; 3D; AF; Ablation; Atrial fibrillation; CT; Computed tomography; EAM; Electro-anatomical mapping; ICE; Intracardiac echocardiography; LSP; Long-standing persistent; MP–DA; MRI; Magnetic Resonance Imaging; P; Pa; Paroxysmal; Persistent; Randomized controlled trial; SP-DF; atrial fibrillation; intracardiac echocardiography; multiple procedure and/or drug assisted; single procedure drug free