Abstract
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. 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. CF and CF stability were correlated with 12-month success for drug-refractory symptomatic AF ablation. CFstability 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. 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. 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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