Cost-effectiveness of percutaneous patent foramen ovale closure versus medical therapy for cryptogenic stroke prevention: A Chinese healthcare perspective.
PFO closure demonstrated economic dominance over medical therapy in Chinese cryptogenic stroke patients, yielding 1.41 additional QALYs while reducing lifetime costs by $4,045 per patient, resulting in a negative ICER of -$2,868 per QALY.
Key Findings
Results
PFO closure was economically dominant over medical therapy, providing more QALYs at lower cost.
PFO closure yielded 13.42 QALYs compared to 12.01 QALYs for medical therapy, a difference of 1.41 additional QALYs.
Lifetime costs were lower with PFO closure ($8,847) than with medical therapy ($12,892), a reduction of $4,045 per patient.
The incremental cost-effectiveness ratio (ICER) was -$2,868 per QALY, indicating superior outcomes at lower cost.
Results were evaluated against China's willingness-to-pay threshold of $37,654 per QALY.
Results
Probabilistic sensitivity analysis showed a high probability of cost-effectiveness for PFO closure at the Chinese willingness-to-pay threshold.
Probabilistic sensitivity analysis revealed a 94.2% probability of cost-effectiveness at the Chinese threshold of $37,654 per QALY.
This analysis was conducted to examine parameter uncertainty and model robustness.
Results
One-way sensitivity analyses consistently produced negative ICERs across all parameter ranges, supporting the robustness of the dominance finding.
One-way sensitivity analyses showed negative ICERs across all parameter ranges tested.
Time horizon and psychological comorbidity costs exerted the greatest influence on results among the parameters examined.
Methods
A Markov cohort model with a 30-year time horizon and Chinese-specific data was used to conduct the cost-effectiveness analysis.
The model included four health states: stable, post-minor recurrent stroke, post-moderate-to-severe recurrent stroke, and death.
Model cycles were 3 months in length over a 30-year time horizon.
The analysis adopted a Chinese healthcare payer perspective.
Transition probabilities were derived primarily from the RESPECT trial extended follow-up data.
Cost data were obtained from multi-center hospital surveys to reflect Chinese-specific costs.
Background
Patent foramen ovale occurs in approximately 25% of cryptogenic stroke patients, with paradoxical embolization as a key pathophysiological mechanism.
The prevalence of PFO in cryptogenic stroke patients is reported as approximately 25%.
Paradoxical embolization is identified as a key pathophysiological mechanism linking PFO to cryptogenic stroke.
Recent trials have established the clinical efficacy of percutaneous PFO closure in reducing recurrent stroke risk.
Chen C, Xu T, Zeng Z, Miao J, Hu R, Gao Y, et al.. (2026). Cost-effectiveness of percutaneous patent foramen ovale closure versus medical therapy for cryptogenic stroke prevention: A Chinese healthcare perspective.. PloS one. https://doi.org/10.1371/journal.pone.0345015