Protamine to expedite vascular hemostasis after catheter ablation of atrial fibrillation: A randomized controlled trial

Abstract

Background: There are no randomized controlled studies of the efficacy and safety of protamine to reverse anticoagulant effects of heparin after catheter ablation (CA) of atrial fibrillation (AF).

Objective: The purpose of this study was to determine the efficacy and safety of protamine to expedite vascular hemostasis and ambulation after CA of AF.

Methods: CA to eliminate AF (n = 139) or left atrial flutter (n = 11) was performed in 150 patients using radiofrequency catheter ablation (n = 112) or cryoballoon ablation (n = 38). CA was performed under uninterrupted anticoagulation with warfarin in 28 patients or after skipping a single dose of a novel oral anticoagulant in 122 patients who were randomized to receive protamine (n = 77) or to the control group (n = 73). Baseline and procedural characteristics were similar between the 2 groups. Hemostasis was achieved manually once the activated clotting time returned to preprocedural values.

Results: The maximum activated clotting time during CA was 359 ± 31 and 359 ± 29 seconds in the protamine and control groups, respectively (P = .91). The time to hemostasis was 123 ± 95 minutes in the protamine group and 260 ± 70 minutes in the control group (P < .001). The time to ambulation was 316 ± 80 and 480 ± 92 minutes in the protamine and control groups, respectively (P < .001). There were no differences in the rates of major or minor vascular access complications or thromboembolic events (P > .05).

Conclusion: Protamine expedites vascular hemostasis and time to ambulation by ∼3 hours after CA of AF without an increase in the risk of vascular or thromboembolic complications.

Keywords: Anticoagulation; Atrial fibrillation; Catheter ablation; Hemostasis; Protamine.