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Background:We assessed cost–effectiveness of insertable cardiac monitors (ICMs) in a US cryptogenic stroke population. Materials & methods:We modelled lifetime costs and quality-adjusted life years for three monitoring strategies post cryptogenic stroke: ICM starting immediately, ICM starting after Holter monitoring (delayed ICM) and standard of care involving intermittent ECG and Holter monitoring. Patient characteristics and detection efficacy were based on the CRYSTAL-AF trial. AF detection altered the modelled anticoagulation therapy and subsequent stroke and bleed risks. Results & conclusion:Immediate ICM was found to be cost-effective versus standard of care and cost-saving versus delayed ICM. Results were robust to sensitivity analyses. ICMs are a cost-effective diagnostic tool for the prevention of recurrent stroke in a US cryptogenic stroke population.

Introduction:Atrial Fibrillation (AF) can be intermittent and have few symptoms. Thus, opportunistic, symptom-based and single time point diagnostics may not suffice for AF management. In contrast, Insertable Cardiac Monitors (ICMs) continuously monitor for arrythmias. The diagnostic performance of devices varies widely and impact the resources needed to monitor ICM patients. Our objective was to assess the resource implications of AF episode Positive Predictive Values (PPV) among available ICMs to US device clinics.Methods:Validation studies for AF indications (syncope, stroke, suspected and known AF) were used to inform a range of real-life PPVs for currently available ICM devices. Reveal LINQ? transmissions over 2014-16 were extracted to determine AF episode incidence. It was assumed there would be no change in true positive rate with varied PPV. Episode review time and costs were simulated for 1 year of device follow-up. Personnel times were sourced from process studies and costs from May 2017 Bureau of Labor Statistics data.Results:A total of 2,843,822 transmissions with ?1 ECGs were identified over 154,682 patient-years; 723,781 contained AF, resulting in a true positive AF episode burden of 4.68 transmissions per patient-year. A PPV of 20% would generate 23.40 AF transmissions in the same patients, including 18.72 false positives. Clinic time evaluating transmissions would total 4.79 hrs per patient-year or 833 hrs per average US clinic (~174 patients managed), equating to $542 per patient-year or $94,364 per year per clinic. Improvement of PPV to 40, 60, 80, or 95% would reduce total transmissions by 50, 67, 75, and 79% respectively compared to 20% baseline. Compared to 20%, a PPV of 95% would generate 2,857,032 or 79% fewer total transmissions, and 99% fewer false positives. This corresponds to a reduction of $352 per patient-year or $61,273 per year per clinic.Conclusion:PPVs substantially impact clinic resource needs and should be carefully considered.

Introduction:The initial indication for the implantable cardiac monitor (ICM) was unexplained syncope; in this population early use of ICM is recommended following initial nondiagnostic workup. ICMs are also increasingly used for arrhythmia management, with detection of AF in patients with risk factors for subsequent stroke being one of the management indications studied in the cost-effectiveness space. Prolonging the longevity of the device may lead to improved clinical outcomes and positive economic impact by increasing the opportunity for arrhythmia diagnosis and treatment. The objective of this analysis is to compare the cost-effectiveness of a 3-year ICM with a 5-year ICM versus conventional testing in unexplained syncope and suspected AF patients, from a U.S. payer perspective.Methods:Economic frameworks have been published for both indications. We used these established frameworks to compare the performance of a device with 3 years of battery longevity against a device of 5 years. All other variables remained equal; the incidence of diagnosable events and diagnostic performance of the device were sourced from published clinical trials (e.g. REVEAL AF, EasyAS) and assumed stable for the additional 2 years of follow-up. Patient outcomes and costs were modeled over a lifetime horizon.Results:In unexplained syncope, 2 additional years of ICM longevity led to a $1,369 or 30% increase in average per-patient cost savings, primarily driven by a reduction in diagnostic testing and injury costs. Per 1,000 patients, 89 syncopal events and 26 injuries were projected to be avoided. In the suspected AF population, a $5,622 or 19% decrease in the incremental cost per life year was observed, from $28,874 to $23,252 per life year. This was driven by a reduction in embolic stroke events through greater AF detection and treatment. Per 1,000 patients, the increased ICM longevity was predicted to prevent 12 additional stroke events.Conclusions:Enhanced battery longevity leads to a significant improvement in the health economic value of these already highly cost-effective technologies. ICM improves outcomes while cutting costs in syncope patients and delivers better outcomes at a cost thought to represent value-for-money in patients with suspected AF.