Contact force sensing for ablation of persistent atrial fibrillation: A randomized, multicenter trial

Abstract

Background Impact of contact force sensing (CFS) on ablation of persistent atrial fibrillation (PeAF) is unknown. Objective The purpose of the TOUCH AF (Therapeutic Outcomes Using Contact force Handling during Ablation of Persistent Atrial Fibrillation) randomized trial was to compare CFS-guided ablation to a CFS-blinded strategy. Methods Patients (n = 128) undergoing first-time ablation for persistent AF were randomized to a CFS-guided vs CFS-blinded strategy. In the CFS-guided procedure, operators visualized real-time force data. In the blinded procedure, force data were hidden. Wide antral pulmonary vein isolation plus a roof line were performed. Patients were followed at 3, 6, 9, and 12 months with clinical visit, ECG, and 48-hour Holter monitoring. The primary endpoint was cumulative radiofrequency (RF) time for all procedures. Atrial arrhythmia >30 seconds after 3 months was a recurrence. Results PeAF was continuous for 26 weeks (interquartile range [IQR] 13–52), and left atrial size was 45 ± 5 mm. Force in the CFS-blinded and CFS-guided arms was 12 g [IQR 6–20] and 14 g [IQR 9–20] (P =.10), respectively. Total RF time did not differ between CFS-guided and CFS-blinded groups (49 ± 14 min vs 50 ± 20 min, respectively; P =.70). Single procedure freedom from atrial arrhythmia was 60% in the CFS-guided arm and 63% in the CFS-blinded arm off drugs. Lesions with gaps were associated with significantly less force (11.4 g [IQR 6–19] vs 13.2 g [IQR 8–20], respectively; P =.0007) and less force-time integral (174 gs [IQR 91–330] vs 210 gs [IQR 113–388], respectively; P