Medtronic’s Reveal Linq Insertable Cardiac Monitor Evaluated for Cost-Effectiveness in STROKE AF Data

February 20, 2024—Medtronic recently announced that new data from the STROKE AF clinical study showed that continuous monitoring with the company’s Reveal Linq insertable cardiac monitor (ICM) is significantly more cost-effective than the standard of care in ischemic stroke patients with large artery and small vessel disease.

The cost-effectiveness analysis reflects data from 492 patients in the STROKE AF study, which was conducted across 33 centers in the United States. In 2014, the company announced FDA clearance and the global launch of the Reveal Linq ICM.

The cost-effectiveness data were presented at the International Stroke Conference 2024 held by the American Heart Association/American Stroke Association on February 7-9 in Phoenix, Arizona.

According to the company, ICM patients in the study were projected to experience 53 fewer ischemic strokes per 1,000 patients over their lifetimes compared to patients receiving the standard of care (such as Holter monitoring, telemetry, or event recorders). The improvement was driven by higher rates of atrial fibrillation (AF) detection and subsequent medication that helps prevent blood clots.

Additionally, patients with ICMs were estimated to experience a gain of 0.17 quality-adjusted life years (QALY) at an incremental cost of $6,286; this led to an incremental cost-effectiveness ratio of $37,760 per QALY, which is well below the established willingness-to-pay threshold in the United States of $150,000 per QALY.

For ICM patients who are at the highest risk of AF detection (those with left atrial enlargement, heart failure, obesity, or prolonged QRS), the cost per QALY is reduced further to $22,016.

Lee H. Schwamm, MD, Associate Dean for Digital Strategy and Transformation for Yale School of Medicine, and Senior Vice President and Chief Digital Health Officer for Yale New Haven Health System in New Haven, Connecticut, commented on the findings in the company’s press release.

“In a model that assumes that risk of stroke derived from prior studies of AF is applicable to patients with ICM-detected AF, use of ICM as an initial strategy is more cost-effective than usual rhythm monitoring care over a lifetime horizon,” stated Dr. Schwamm. “This is due to more frequent AF detection with greater and earlier opportunities to initiate anticoagulation to prevent future AF-related secondary strokes.”

He continued, “This economic value analysis demonstrates ICMs may be a highly cost-effective strategy for the prevention of recurrent stroke in patients with large artery and small vessel disease, with results similar to the cost analysis findings in the landmark CRYSTAL-AF study of cryptogenic stroke patients.”

The company noted that findings from the STROKE AF clinical study was recently published in JAMA Neurology (2023;80:1277-1283). The data showed that large and small vessel disease stroke patients had a 10-fold increase in AF detection with the Reveal Linq ICM at 3 years compared to patients randomized to standard of care. The study also showed that 67% of patients in the ICM arm had at least one clinically relevant AF episode lasting more than 1 hour in duration, while 88% of AF episodes were asymptomatic.

Until now, the cost-effectiveness of ICMs in this large artery and small vessel ischemic stroke patient population remained unknown, stated Medtronic.