Vivek Y Reddy1, Scott Pollak2, Bruce D Lindsay3, H Thomas McElderry4, Andrea Natale5, Charan Kantipudi6, Moussa Mansour7, Daniel P Melby8, Dhanunjaya Lakkireddy9, Tzachi Levy10, David Izraeli11, Chithra Sangli11, David Wilber12. 1. Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: vivek.reddy@mountsinai.org. 2. Florida Hospital, Cardiovascular Research, Orlando, Florida, USA. 3. Cleveland Clinic Foundation, Cleveland, Ohio, USA. 4. University of Alabama, Birmingham, Alabama, USA. 5. Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, USA. 6. Piedmont Heart Institute, Atlanta, Georgia, USA. 7. Massachusetts General Hospital, Cardiac Arrhythmia Center, Boston, Massachusetts, USA. 8. Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. 9. University of Kansas, Mid-America Cardiology, Kansas City, Kansas, USA. 10. Biosense Webster (Israel) Ltd., Yokneam, Israel. 11. Biosense Webster Inc., Diamond Bar, California, USA. 12. Loyola University Medical Center, Maywood, Illinois, USA.
Abstract
OBJECTIVES: This study sought to assess the correlation between catheter and tissue contact force (CF) stability and 12-month clinical success for atrial fibrillation (AF) ablation. BACKGROUND: The SMART-AF (Thermocool Smarttouch Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation) multicenter trial provided a robust dataset of AF ablation procedures, using the CF sensing ablation catheter. METHODS: CF and CF stability were correlated with 12-month success for drug-refractory symptomatic AF ablation. CF stability was assessed by stability of ablation parameters (CF, time, location stability) over 3-dimensional electroanatomic maps of pulmonary veins (PVs) using a new proprietary software module and the percentage of time within investigator-selected CF ranges. Available data for potential "PV gaps" were retrospectively identified when stability criteria were not met and were correlated with 12-month success. RESULTS: Average CF categories of 0 to 10, 10 to 20, and >20 g were associated with 12-month success rates of 90%, 70%, and 70%, respectively; thus, higher average CF did not correlate with treatment success. An exploratory univariate analysis showed significantly higher success rates with a CF of 6.5 to 10.3 g than with <6.5 g (odds ratio: 2.95; 95% confidence interval: 1.13 to 7.72; p = 0.028) but a CF >10 g did not improve success. When stable CF was applied ≥73% of the time within the preselected CF range, success improved. A receiver operating characteristic curve analysis revealed that PV gaps exceeding 10.6-mm distance significantly correlated with 12-month failure. CONCLUSIONS: In the SMART-AF trial, CF stability with sufficient CF was most predictive of optimal 12-month success. (Thermocool Smarttouch Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation [SMART-AF]; NCT01385202).
OBJECTIVES: This study sought to assess the correlation between catheter and tissue contact force (CF) stability and 12-month clinical success for atrial fibrillation (AF) ablation. BACKGROUND: The SMART-AF (Thermocool Smarttouch Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation) multicenter trial provided a robust dataset of AF ablation procedures, using the CF sensing ablation catheter. METHODS: CF and CF stability were correlated with 12-month success for drug-refractory symptomatic AF ablation. CF stability was assessed by stability of ablation parameters (CF, time, location stability) over 3-dimensional electroanatomic maps of pulmonary veins (PVs) using a new proprietary software module and the percentage of time within investigator-selected CF ranges. Available data for potential "PV gaps" were retrospectively identified when stability criteria were not met and were correlated with 12-month success. RESULTS: Average CF categories of 0 to 10, 10 to 20, and >20 g were associated with 12-month success rates of 90%, 70%, and 70%, respectively; thus, higher average CF did not correlate with treatment success. An exploratory univariate analysis showed significantly higher success rates with a CF of 6.5 to 10.3 g than with <6.5 g (odds ratio: 2.95; 95% confidence interval: 1.13 to 7.72; p = 0.028) but a CF >10 g did not improve success. When stable CF was applied ≥73% of the time within the preselected CF range, success improved. A receiver operating characteristic curve analysis revealed that PV gaps exceeding 10.6-mm distance significantly correlated with 12-month failure. CONCLUSIONS: In the SMART-AF trial, CF stability with sufficient CF was most predictive of optimal 12-month success. (Thermocool Smarttouch Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation [SMART-AF]; NCT01385202).
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