Jonathan W Waks1, Rod S Passman2, Jason Matos1, Matthew Reynolds3, Amit Thosani4, Theofanie Mela5, David Pederson6, Taya V Glotzer7, Peter Zimetbaum8. 1. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. 2. Northwestern University Feinberg School of Medicine, Chicago, Illinois. 3. Lahey Health, Burlington, Massachusetts. 4. Allegheny General Hospital, Pittsburgh, Pennsylvania. 5. Massachusetts General Hospital, Boston, Massachusetts. 6. STAR Clinical Trials, San Antonio, Texas. 7. Hackensack University Medical Center, Hackensack, New Jersey. 8. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: pzimetba@bidmc.harvard.edu.
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.
RCT Entities:
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.
Authors: Alexander C Perino; Jun Fan; Mariam Askari; Paul A Heidenreich; Edmund Keung; Merritt H Raitt; Jonathan P Piccini; Paul D Ziegler; Mintu P Turakhia Journal: Circulation Date: 2019-03-17 Impact factor: 29.690
Authors: Agnieszka Kotalczyk; Michał Mazurek; Zbigniew Kalarus; Tatjana S Potpara; Gregory Y H Lip Journal: Nat Rev Cardiol Date: 2020-10-27 Impact factor: 32.419