Randomized trial comparing pulmonary vein isolation using the SmartTouch catheter with or without real-time contact force data

BACKGROUND Contact force (CF) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation (PAF). OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF. METHODS Patients undergoing first-time PAF ablation were randomized at 7 UK centers to ablation with (CF-on) or without (CF-off) CF data available to the operator, using the same ablation catheter and mapping system. An ablation CF of 5-40g was targeted. Pulmonary vein (PV) reconnection was assessed with adenosine at 60 minutes. Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months. RESULTS One hundred seventeen patients were studied (59 CF-on, 58 CF-off). In the CF-on group, a reduction in acute PV reconnection rates (22% vs 32%, P = .03) but no significant difference in 1-year success rates off antiarrhythmic drugs (49% vs 52%, P = .9) was observed. There was no difference in major complication rates: 2 of 59 (3%) CF-on, 3 of 58 (5%) CF-off (P = .7). Procedural and fluoroscopy times were not significantly different (P>.5). Overall mean CFs per ablation were not different between groups (13.4 [9.1-19.6]g CF-on, 13.4 [7.4-22.4]g CF-off, P = .5), but a greater proportion of readings in the CF-on group were in the target range (80% vs 68%, P<.001). CONCLUSION This randomized multicenter study demonstrated that CF data availability was associated with reduced acute PV reconnection but not improved 1-year success rates, procedural and fluoroscopy times, or complication rates. There was a reduction in extremes of CF, above and below the study target range, suggesting greater CF control during ablation. (C) 2016 Heart Rhythm Society. All rights reserved.