Digital health-enabled monitoring strategies for atrial fibrillation detection after embolic stroke of undetermined source : a cost-effectiveness analysis of implantable loop recorders, wearable devices, and usual care

Introduction: Embolic stroke of undetermined source (ESUS) is frequently attributable to atrial fibrillation (AF), yet remains undetected when episodes are brief or asymptomatic. Digital health-enabled cardiac monitoring offers novel pathways for secondary prevention. Implantable loop recorders (ILRs) provide continuous long-term rhythm surveillance, while wearable electrocardiogram (ECG) devices offer greater accessibility but with uncertain diagnostic yield and economic value. We evaluated the cost-effectiveness of ILR versus wearable AF monitoring and usual care in ESUS. Methods: A cohort-based Markov model simulated 1,000 ESUS patients (mean age 65 years) over a 10-year horizon from the German statutory health insurance perspective. Clinical inputs included AF detection rates (ILR: 15–25%; wearables: 5–10%), risk reduction in ischemic stroke with oral anticoagulation (OAC), and mortality/disability utilities. Costs (EUR 2,024, 3% discount) captured device acquisition, implantation, follow-up, stroke care, and OAC therapy. Outcomes included incremental cost-effectiveness ratio (ICER) and incremental net monetary benefit at willingness-to-pay thresholds of EUR 20,000, EUR 30,000, and EUR 50,000/quality-adjusted life-year (QALY). Deterministic and probabilistic sensitivity analyses, including expected value of perfect information (EVPI), were performed. Results: ILR yielded 0.23 additional QALYs compared with wearables at an incremental cost of EUR 2,160, resulting in a base-case ICER of EUR 9,391/QALY. In a high-risk subgroup, the ICER decreased to EUR 5,520/QALY. Probabilistic analysis demonstrated >90% probability of cost-effectiveness at EUR 30,000/QALY, with moderate EVPI. These findings align with meta-analytic evidence (RR 3.88 for AF detection; RR 0.75 for stroke reduction) and indicate that prolonged monitoring (≥12 months) maximizes yield. Conclusion: Digital health-enabled ILR monitoring is likely cost-effective for AF detection after ESUS, particularly in high-risk patients. Wearables may serve as an adjunct but deliver lower value. Results support targeted ILR implementation in post-ESUS care pathways and integration into digital health-driven guideline and reimbursement frameworks.