OBJECTIVES: This study aimed to evaluate the annual economic burden of PFO-related cryptogenic stroke in the U.S. Stroke, claiming 3.3 million lives annually and resulting in the loss of 143 million disability-adjusted life-years globally, stands as the second most common cause of death and the third leading contributor to death and disability worldwide. In the U.S., 692,000 cases of ischemic stroke occur annually, with 25%–40% classified as cryptogenic strokes and 40%–50% of these exhibiting patent foramen ovale (PFO).

METHODS: A cost-of-illness study was performed, encompassing the direct and indirect costs of PFO-associated cryptogenic stroke on both society and the health care system. The model adopted a one-year time horizon to incorporate PFO-related cryptogenic stroke incidence into the costs associated with stroke in the U.S., with both a societal and a payer perspective.

RESULTS: The societal model, assuming 32.5% cryptogenic strokes, incurs an annual cost of $2,190,950,335 in the U.S., with $1,681,106,547 coming from new strokes and $509,843,789 from recurrent strokes. The majority of costs are attributed to indirect costs, accounting for 50% from productivity losses due to premature death and 27% from other productivity losses. Direct costs constitute 23% of the total. From the payer perspective, the annual costs for PFO-related cryptogenic strokes in the U.S. were estimated at $504,244,294, with hospitalization costs comprising 44%, followed by prescriptions and outpatient care at 19% and 16%, respectively.

CONCLUSIONS: The economic burden of PFO-related cryptogenic strokes in the U.S. is substantial, exceeding $2.1 billion per year. PFO occluders play a central role alongside medical management in the prevention of recurrent PFO-related cryptogenic stroke leading to gains in both costs and health outcomes. Further research will be required to quantify these possible gains accurately.