Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study

J Interv Card Electrophysiol. 2016 Aug;46(2):97-103. doi: 10.1007/s10840-016-0102-0. Epub 2016 Jan 21.

Abstract

Purpose: 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.

Keywords: Atrial fibrillation; Catheter ablation; Contact force; Pulmonary vein isolation; Robotic navigation system.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Atrial Fibrillation / diagnostic imaging
  • Atrial Fibrillation / surgery*
  • Body Surface Potential Mapping / instrumentation*
  • Catheter Ablation / instrumentation*
  • Equipment Design
  • Equipment Failure Analysis
  • Female
  • Humans
  • Male
  • Man-Machine Systems*
  • Middle Aged
  • Reproducibility of Results
  • Robotic Surgical Procedures / instrumentation*
  • Sensitivity and Specificity
  • Stress, Mechanical*
  • Touch
  • Transducers, Pressure
  • Treatment Outcome