Introduction: After diagnosis of atrial fibrillation (AF), oral anticoagulation (OAC) is taken daily and may increase risk of bleeding, even during AF-free periods. We explored temporal discordance between AF and major bleeding events (MBE) in patients with cardiovascular implantable electronic devices (CIED).
Methods: We linked Veterans Administration (VA) and Medicare data to CIED remote monitoring data. Analyses were restricted to Medtronic cardiac rhythm devices with atrial leads, which provide a daily, continuous measure of AF burden. We identified the earliest date of monitoring and searched for a subsequent MBE (including but not limited to intracranial hemorrhaging, gastrointestinal bleeds, and vascular bleeds) from 2004 to 2015. We restricted analysis to patients with <75% coverage of remote monitoring in the 90 days before and after MBE and with OAC prescription and pill coverage in the 90 days prior and on day of MBE. Patients were categorized into 4 groups based on the presence of AF ≥ 6 minutes on any of the 90 days on or prior to MBE and 90 days after MBE: NO/NO, NO/YES, YES/NO, YES/YES.
Results: There were 189 patients meeting inclusion criteria (69±9.4 years, CHA2DS2-VASc 4.3±1.4). Of these, 99 (52%) of patients had no AF≥ 6 min in the 90 days on or before MBE (NO/NO). Among all patients, there were 3 ischemic strokes, 2 ICH, 33 MBE, and 83 deaths following the index MBE. Across all categories, the risk of recurrent MBE and death was substantially higher than stroke or ICH and only 7% with no AF pre had AF post (NO/YES). (TABLE)
Conclusion: Among CIED patients on OAC, most did not have AF at the time of MBE. Risk of MBE and death was substantially higher than stroke or ICH and call into question rationale to remain on indefinite OAC. Long-term AF monitoring may prove useful and requires evaluation.