Cost-effectiveness Of Insertable Cardiac Monitors For Detection Of Undiagnosed Atrial Fibrillation In High-risk Patients With Heart Failure

Abstract

<h3>Introduction</h3> Atrial fibrillation (AF) is a major risk factor for stroke, the risk of which is mitigated through AF detection and subsequent treatment with oral anticoagulation. The REVEAL AF study demonstrated that ICMs detect a high rate of AF in high-risk patients, and a resulting cost-effectiveness analysis found ICM use to be cost-effective in preventing strokes. Given the known deleterious relationship between AF and heart failure (HF), this analysis sought to examine the cost effectiveness of ICMs in the sub-population of the REVEAL AF study with HF. <h3>Methods</h3> A lifetime Markov model assessed the cost-effectiveness of ICM vs. SoC from a US payer perspective. Patient characteristics, health utilities, and AF detection rates for the ICM group were based on the heart failure subgroup within the REVEAL-AF study (N=81). Standard of care AF detection rates were based on a subsequent simulation of the REVEAL-AF study. The observed two-year AF diagnostic yields of 38.4% with ICM and 1.4% in SoC were extrapolated to the 3-year device lifespan using logarithmic extrapolation (ICM = 43.8%; SOC=1.7%). AF detection was assumed to prompt switching from aspirin to direct oral anticoagulation (DOAC), unless precluded by prior bleeds. Subsequent risks of ischemic strokes and bleeding events were modeled based on published literature. U.S. payer-perspective costs, extracted from Medicare and commercial payer administrative datasets, and drug effects were discounted at 3% annually. <h3>Results</h3> ICM in REVEAL-AF sub-population with HF was associated with a 0.19 quality-adjusted life year (QALY) gain compared to SoC (7.11 vs. 6.92) and $5,895 higher per-patient costs, resulting in an incremental cost-effectiveness ratio (ICER) of $31,452 per QALY gained. In sensitivity analyses, where we assumed no further AF was detected after 2 years (38.4% diagnostic yield at year 3), the ICER increased to $35,358, whereas a linear extrapolation (48% diagnostic yield at year 3) reduced the ICER to $29,026. The ICER was also sensitive to use of warfarin (ICER=$49,525) rather than DOAC anticoagulation in the base case analysis, and device and insertion procedure cost (+/- 30%: ICER=$42,724; $20,179, respectively). Further, increasing the device longevity to 4.5 years yielded an ICER of $29,146. <h3>Conclusions</h3> ICMs are a cost-effective diagnostic tool for the prevention of ischemic strokes in patients with heart failure and at high risk for atrial fibrillation. Improvements in ICM battery life could further enhance their clinical and economic value.