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

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, CHADS(2) 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% CHADS(2) 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-tomoderate 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.