title: Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study.
abstract: OBJECTIVE
  Contact with cardiac tissue is an important determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei X™ robotic navigation system (RNS) (Hansen Medical, Mountain View, CA, USA) has been validated for contact force (CF) sensing expressed in grams (g). The Thermocool® SmartTouch™ catheter enables the measurement of catheter tip CF and direction inside the heart. We aimed to investigate the catheter CF with and without RNS during pulmonary vein isolation (PVI) procedures.
  
  
  METHODS
  Eighty patients with symptomatic AF (56 males, age 63 ± 18) were enrolled in this study. Fifty-seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter. Forty patients were randomized to perform PVI with the Sensei X™ RNS (group 1), while in the other 40 patients (group 2), PVI was performed without the RNS.
  
  
  RESULTS
  AF ablation was performed successfully in all patients without complications, while contact force was kept in the established 10-40 g range. A significantly higher CF was documented on the PVs in group 1 compared to group 2. The 1-year freedom from AF recurrence was higher in group 1 compared to group 2 (90 vs. 65 %, p = 0.04). Moreover, a significant reduction of fluoroscopy time was noted in the RNS group (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05).
  
  
  CONCLUSIONS
  The Sensei X™ RNS permits a significantly higher CF during transcatheter AF ablation with a low rate of AF recurrence at clinical follow-up.
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Dello Russo
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Fassini
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy. sergioconti.md@gmail.com.
authors.forename: Sergio
authors.initials: S
authors.lastname: Conti
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Casella
authors.affiliation: Catholic University of Sacred Heart, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Di Monaco
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Russo
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Riva
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Moltrasio
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Tundo
authors.affiliation: Casa di Cura Montevergine, Mercogliano, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Martino
authors.affiliation: Texas Cardiac Arrhythmia Institute at St David's Medical Centre, Austin, TX, USA.
authors.forename: G Joseph
authors.initials: GJ
authors.lastname: Gallinghouse
authors.affiliation: Texas Cardiac Arrhythmia Institute at St David's Medical Centre, Austin, TX, USA.|Albert Einstein College of Medicine at Montefiore Hospital, New York, NY, USA.|Cardiology Department, University of Foggia, Foggia, Italy.|Department of Biomedical Engineering, University of Texas, Austin, TX, USA.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.affiliation: Texas Cardiac Arrhythmia Institute at St David's Medical Centre, Austin, TX, USA.|Department of Biomedical Engineering, University of Texas, Austin, TX, USA.|Division of Cardiology, Stanford University, Stanford, CA, USA.|Case Western Reserve University, Cleveland, OH, USA.|EP Services, California Pacific Medical Center, San Francisco, CA, USA.|Interventional Electrophysiology, Scripps Clinic, San Diego, CA, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.affiliation: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.|Texas Cardiac Arrhythmia Institute at St David's Medical Centre, Austin, TX, USA.
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
mesh_terms: D001281:Atrial Fibrillation / Q000000981:diagnostic imaging / Q000601:surgery*; D018780:Body Surface Potential Mapping / Q000295:instrumentation*; D017115:Catheter Ablation / Q000295:instrumentation*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D008297:Male; D008328:Man-Machine Systems; D008875:Middle Aged; D015203:Reproducibility of Results; D065287:Robotic Surgical Procedures / Q000295:instrumentation*; D012680:Sensitivity and Specificity; D013314:Stress, Mechanical; D014110:Touch; D014160:Transducers, Pressure; D016896:Treatment Outcome
keywords: Atrial fibrillation; Catheter ablation; Contact force; Pulmonary vein isolation; Robotic navigation system