The annual economic burden of patent foramen ovale-associated stroke in the United States

Background: Stroke is the second leading cause of death worldwide and the third leading cause of death and disability combined. Among ischemic strokes, 25 % to 40 % are classified as cryptogenic, with patent foramen ovale (PFO) identified as a potential underlying cause. PFO is found in 25 % of the general population. Despite the significant occurrence of PFO-associated strokes, the associated costs remain largely unexplored. Aim: This study aimed to evaluate the annual economic burden of PFO-associated stroke in the US. Methods: A cost-of-illness study was performed, encompassing the direct and indirect costs of PFO-associated stroke on both society and the healthcare system. The model adopted a top-down approach and a one-year, US societal perspective. A payer perspective and bottom-up costing approach were included as scenario analyses. Data was obtained by a targeted literature review. Results: The societal model, assuming 32.5 % cryptogenic strokes, incurs an annual cost of over $1.3 billion in the US, with over $1.0 billion coming from new strokes and over $300 million from recurrent strokes. The majority of the costs are indirect—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-associated strokes in the US were estimated at $302 million, with hospitalization costs comprising 44 %, followed by prescriptions and outpatient care at 19 % and 16 %, respectively. Conclusion: The economic burden of PFO-associated strokes in the US is substantial, exceeding $1.3 billion per year. Different types of medical management or surgical treatments for PFO-associated stroke could lead to gains in both costs and health outcomes.