Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study

Heart Rhythm. 2018 Nov;15(11):1601-1607. doi: 10.1016/j.hrthm.2018.06.027. Epub 2018 Jul 6.

Abstract

Background: Chronic anticoagulation is recommended for atrial fibrillation (AF) patients with thromboembolic risk factors regardless of AF duration/frequency. Continuous rhythm assessment with pacemakers (PMs)/implantable cardioverter-defibrillators (ICDs) and use of direct-acting oral anticoagulants (DOACs) may allow anticoagulation only around AF episodes, reducing bleeding without increasing thromboembolic risk.

Objective: The purpose of this study was to evaluate the feasibility/safety of intermittent DOAC use guided by continuous remote AF monitoring via dual-chamber PMs or ICDs.

Methods: Patients with nonpermanent AF, current DOAC use, CHADS2 score ≤3, a St. Jude Medical dual-chamber PM or ICD, and rare AF episodes were followed with biweekly and AF-alert based remote transmissions. Patients free of AF episodes lasting ≥6 minutes with a total AF burden <6 hours/day for 30 consecutive days discontinued DOAC. If AF burden surpassed these limits, DOAC was restarted and/or continued. Total days on DOAC and adverse events were assessed.

Results: Among 48 patients (mean age 71.3 years; 65% male; 79% paroxysmal AF; 87% CHADS2 score 1-2), 14,826 days of monitoring were completed. Patients used DOACs for 3763 days, representing a 74.6% reduction in anticoagulation time compared to chronic administration. Adverse events included 2 gastrointestinal bleeds (both on DOAC), 1 fatal intracerebral bleed (off DOAC), and no thromboembolic/stroke events.

Conclusion: Among patients with rare AF episodes and low-to-moderate stroke risk, PM/ICD-guided DOAC administration is feasible and decreased anticoagulation utilization by 75%. Few adverse events occurred, although the study was not powered to assess these outcomes. PM/ICD-guided DOAC administration may prove a viable alternative to chronic anticoagulation. Future studies are warranted.

Keywords: Anticoagulation; Atrial fibrillation; Cardiac implantable electronic device; Remote monitoring; Stroke; Thromboembolism.

Publication types

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

MeSH terms

  • Aged
  • Anticoagulants / administration & dosage*
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / therapy*
  • Defibrillators, Implantable*
  • Dose-Response Relationship, Drug
  • Electrocardiography
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Monitoring, Physiologic / methods*
  • Pacemaker, Artificial*
  • Pilot Projects
  • Risk Factors
  • Stroke / etiology
  • Stroke / prevention & control*
  • Telemetry / methods*
  • Time Factors
  • Treatment Outcome

Substances

  • Anticoagulants