title: A novel radiofrequency ablation catheter using contact force sensing: Toccata study.
abstract: OBJECTIVE
  The aim of this multicenter study was to evaluate the device- and procedure-related safety of a novel force-sensing radiofrequency (RF) ablation catheter capable of measuring the real-time contact force (CF) and to present CF data and its possible implications on patient safety.
  
  
  BACKGROUND
  The clinical outcome of RF ablation for the treatment of cardiac arrhythmias may be affected by the CF between the catheter tip and the tissue. Insufficient CF may result in an ineffective lesion, whereas excessive CF may result in complications.
  
  
  METHODS
  Seventy-seven patients (43 with right-sided supraventricular tachycardia [SVT] and 34 with atrial fibrillation [AF]) received percutaneous ablation with the novel studied catheter. The CF applied and safety events related to the procedure were reported.
  
  
  RESULTS
  CF values at mapping ranged from 8 ± 8 to 60 ± 35 g and from 12 ± 10 to 39 ± 29 g in the SVT group and the LA group, respectively, showing a significant interinvestigator variability (P < .0001). High transient CFs (>100 g) were noted in 27 patients (79%) of the LA group. One device-related complication (tamponade, 3%) occurred in the AF group.
  
  
  CONCLUSIONS
  Catheter ablation using real-time CF technology is safe for the treatment of SVT and AF. High CFs may occur during catheter manipulation and not just during ablation, suggesting that measuring CF may provide additional useful information to the operator for safe catheter manipulation. In the future, CF-sensing catheters may also increase the effectiveness of RF ablations by allowing better control of the RF lesion size.
authors.affiliation: Abt. Kardiologie, Asklepios Klinik St. Georg, Hamburg, Germany. kuckkh@asklepios.com
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
authors.forename: Boris
authors.initials: B
authors.lastname: Schmidt
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.forename: Nadir
authors.initials: N
authors.lastname: Saoudi
authors.forename: Josef
authors.initials: J
authors.lastname: Kautzner
authors.forename: Claudia
authors.initials: C
authors.lastname: Herrera
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hindricks
authors.forename: Pierre
authors.initials: P
authors.lastname: Jaïs
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakagawa
authors.forename: Hendrik
authors.initials: H
authors.lastname: Lambert
authors.forename: Dipen C
authors.initials: DC
authors.lastname: Shah
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000601:surgery*; D001281:Atrial Fibrillation / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D013617:Tachycardia, Supraventricular / Q000601:surgery*; D016896:Treatment Outcome