Recurrent atrial arrhythmia in a randomized controlled trial comparing contact force guided and contact force blinded ablation for typical atrial flutter

Abstract

Background: Contact force (CF) guided catheter ablation (CA) is a novel technology developed to improve efficacy and reduce complications. In a randomised controlled trial (RCT), we previously documented that after three months, rate of persistent conduction block was similar with and without using CF while performing CA for typical atrial flutter (AFL). Clinical effect of CF on recurrent arrhythmia is unknown. Objective: To study recurrent atrial arrhythmia during 12-months follow-up in a RCT investigating whether CF-guided CA for typical AFL is superior to CF-blinded CA. Method: Patients were randomized 1:1 to CA guided by CF (intervention group) or blinded to CF (control group). After 12 months, patients attended clinical check-up preceded by a 5-day ambulatory Holter monitor recording. Primary outcome was any recurrent atrial arrhythmia ≥30 seconds within 12 months, symptomatic or asymptomatic and documented in 12-lead ECG or Holter monitor recording. We did intention-to-treat (ITT) analysis. Results: We included and randomized 156 patients, four patients withdrew consent and two died during follow-up. Thus, 150 patients were included in ITT-analysis, in which recurrent arrhythmia was detected in 47 (31%) patients, 25 in the intervention group and 22 in the control group (p = 0.25). Atrial fibrillation was detected in 38 patients (18 versus 20 patients), and AFL in the remaining 9 patients (7 versus 2 patients). Conclusion: Contact force guided ablation for typical atrial flutter does not reduce recurrent atrial arrhythmia after 12-months follow-up as compared with ablation blinded for contact force.