16-19: Real-world Data of Persistent AF Ablation With CF-Sensing Catheter

Abstract

Purpose of the study: In this multicentre observational registry, we evaluated the real-world clinical experience of persistent atrial fibrillation (AF) ablation using THERMOCOOL SMARTTOUCH® Catheter. Method used: Patients with persistent AF (excluding long-standing persistent AF) ablation were enrolled and followed for 12-month (M) with a 3-M blanking period. We assessed the early-onset (≤7 days of index procedure) primary AEs, 12-M success (patient-reported freedom from symptomatic AF recurrence) and correlation of success with contact force (CF). Summary of results: A total of 152 patients (age, 61.5 ± 9.4 years; 76.3% males; 90.8% Caucasian; LVEF, 56.9 ± 10.1%; left atrial diameter, 41.8 ± 7.9 mm) underwent catheter insertion and comprised the safety cohort. Effectiveness was assessed from the evaluable cohort; 144 patients who met inclusion/exclusion criteria and received RF ablation. Primary AE rate was 3.9% (6/152) and the 12-M success was 63.3% (95% CI: 54.4-70.9%). Among patients with available CF data (n = 93), 72% and 19.4% of the procedures were set at a CF range of 5-40 g and 10-40 g, respectively. Mean (SD) CF for safety and evaluable cohorts was 16.2 (4.0) g and 16.1 (4.0) g, respectively. Investigators stayed within pre-selected CF range 79.7 ± 12.7% of the time. A trend of correlation of higher CF with 12-M effectiveness (OR: 1.12, 95% CI: 0.99-1.27, P = 0.080) was observed. Furthermore, long-term success is likely to increase when investigators stay within CF range ≥80% vs <80% of the time (69.2% vs 58.5%; P = 0.285). Conclusion: In this preliminary report of persistent AF ablation using the THERMOCOOL SMARTTOUCH® catheter from real-world registry, 12M success was 63.3% and trended non-significantly towards improved success when operators stayed within their pre-selected CF range ≥80% of time.