Antonio Dello Russo1, Gaetano Fassini1, Sergio Conti2, Michela Casella1, Antonio Di Monaco3, Eleonora Russo1, Stefania Riva1, Massimo Moltrasio1, Fabrizio Tundo1, Giuseppe De Martino4, G Joseph Gallinghouse5, Luigi Di Biase5,6,7,8, Andrea Natale5,8,9,10,11,12, Claudio Tondo1,5. 1. Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy. 2. Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy. sergioconti.md@gmail.com. 3. Catholic University of Sacred Heart, Rome, Italy. 4. Casa di Cura Montevergine, Mercogliano, Italy. 5. Texas Cardiac Arrhythmia Institute at St David's Medical Centre, Austin, TX, USA. 6. Albert Einstein College of Medicine at Montefiore Hospital, New York, NY, USA. 7. Cardiology Department, University of Foggia, Foggia, Italy. 8. Department of Biomedical Engineering, University of Texas, Austin, TX, USA. 9. Division of Cardiology, Stanford University, Stanford, CA, USA. 10. Case Western Reserve University, Cleveland, OH, USA. 11. EP Services, California Pacific Medical Center, San Francisco, CA, USA. 12. Interventional Electrophysiology, Scripps Clinic, San Diego, CA, USA.
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.
RCT Entities:
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.
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