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

Heart Rhythm. 2018 Nov;15(11):1642-1647. doi: 10.1016/j.hrthm.2018.06.045. Epub 2018 Jul 3.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use
  • Atrial Fibrillation / blood
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / surgery*
  • Blood Coagulation / drug effects*
  • Catheter Ablation / methods*
  • Drug Administration Schedule
  • Female
  • Hemorrhage / blood
  • Hemorrhage / chemically induced
  • Hemorrhage / prevention & control*
  • Heparin Antagonists / administration & dosage
  • Humans
  • Male
  • Middle Aged
  • Postoperative Period
  • Protamines / administration & dosage*
  • Thromboembolism / blood
  • Thromboembolism / etiology
  • Thromboembolism / prevention & control
  • Treatment Outcome
  • Warfarin / adverse effects
  • Warfarin / therapeutic use

Substances

  • Anticoagulants
  • Heparin Antagonists
  • Protamines
  • Warfarin