Abstract

Background: Patients with atrial fibrillation (AF) and stroke risk factors are recommended for treatment with long-term anticoagulation, even when rhythm control interventions result in a low AF burden. A strategy of guiding anticoagulation with novel oral anticoagulants (NOACs) based on daily transmissions from an implantable cardiac monitor (ICM) in CHADS 2 1 or 2 AF patients has recently been explored in a single-arm pilot study. The aim of our study was to evaluate the cost-effectiveness of this strategy versus projected outcomes with the current standard of continuous anticoagulation. Methods: We developed a Markov model using data from the Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT.COM) pilot study (N=59) and previously completed anticoagulant trials to calculate the costs and quality-adjusted life years (QALYs) associated with ICM-guided intermittent anticoagulation for AF vs. standard care. The model time horizon was 3 years (the battery life of an ICM). Health state utilities were estimated from the pilot study population using the SF-12. Costs were based on current Medicare reimbursement. Results: In the pilot study, over 14±4 months of follow-up 18/59 patients were observed to have 35 AF episodes, 60% of which spontaneously terminated and 63% were asymptomatic. The protocol resulted in a >90% reduction in anticoagulant use relative to standard continuous treatment. There were no strokes, 2 (3.4%) TIAs, 2 major bleeding events (on aspirin) and 3 minor bleeding events with the ICM-guided strategy. The model projected total 3-year costs of $10,558 for the ICM-guided strategy vs. $12,898 for literature-based expected outcomes with continuous anticoagulation. Projected QALYs were 2.46 for both groups. Detailed sensitivity and scenario analyses are ongoing. Conclusions: Based on the REACT.COM pilot study, a strategy of intermittent, ICM-guided oral anticoagulation with NOACs was cost-saving relative to expected outcomes with continuous anticoagulation, with equivalent quality-adjusted survival. This strategy requires validation in a larger, randomized study.

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