Protamine administration after catheter ablation of atrial fibrillation using electroporation: a randomized controlled trial

Abstract Background Safety of protamine administration after catheter ablation of atrial fibrillation (AF) using pulse-field system has not been previously described in a prospective randomized trial. Methods Consecutive patients with paroxysmal, persistent or long-standing persistent AF undergoing catheter ablation of AF using Farapulse system were randomly assigned in 1:1 ratio for protamine administration before sheaths removal. All vascular punctions were navigated using a direct ultrasound control. Right femoral vein was used for FaraDrive (16 F) sheath and left femoral vein for ICE (11 F) and decapolar diagnostic catheter (7 F). All sheaths were removed immediately at the end of procedure with subsequent local haemostasis with figure-of-eight suture. Primary endpoint was early and late access site complications. Secondary endpoints were significant bleeding, thromboembolic events and duration of hospital stay. Results 428 consecutive patients were enlisted into the study (213 in protamine group; 215 in control group). Baseline and procedural characteristics were similar between both groups. ACT before venous sheath removal was higher in patients not receiving protamine (330.1 ± 38.6 vs. 189.3 ± 44.7 seconds, P < 0.001). There were no significant differences in both primary and secondary endpoints between both groups: groin hematoma (5 vs 5; p = NS); there were no thromboembolic complications in both groups and no significant differences of hospital stay duration. Conclusion Protamine administration after atrial fibrillation ablation using Farapulse system is not necessary when using ultrasound navigated vascular access and haemostasis with figure of eight suture.