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Updated: Nov 1, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Cost-Effectiveness Analysis of Percutaneous Patent Foramen Ovale Closure Preventing Secondary Ischemic Stroke in
Sachie Inoue1, Ataru Igarashi2, Yasuyuki Iguchi3
1CRECON Medical Assessment Inc., Tokyo, Japan.
Insights
Patent foramen ovale closure is more effective and less costly than medical therapy for preventing recurrent ischemic stroke in Japanese patients. This cost-effective intervention significantly improves quality-adjusted life years.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Health Economics
Background:
- Patent foramen ovale (PFO) is an atrial communication linked to cryptogenic ischemic stroke.
- Percutaneous PFO closure is a strategy to reduce recurrent stroke risk.
- Cost-effectiveness of PFO closure in Japan remained unevaluated.
Purpose of the Study:
- To evaluate the cost-effectiveness of percutaneous PFO closure versus medical therapy.
- To assess the economic impact in Japanese patients following their first cryptogenic ischemic stroke.
Main Methods:
- A Markov model was employed to compare PFO closure and medical therapy.
- Quality-adjusted life years (QALYs) measured effectiveness; a 2% discount rate was applied.
- Data from the RESPECT trial (Amplatzer™ PFO Occluder) informed the analysis.
Main Results:
- PFO closure demonstrated dominance over medical therapy.
- This resulted in an average gain of 2.53 QALYs and cost savings of 2,353,926 JPY.
- The probability of PFO closure being dominant was 82.9%.
Conclusions:
- Patent foramen ovale closure is a dominant strategy over medical therapy for secondary stroke prevention.
- This approach is cost-effective for patients with cryptogenic ischemic stroke in Japan.
Objectives:
Patent foramen ovale is a hemodynamically insignificant interatrial communication that may cause ischemic stroke. Percutaneous patent foramen ovale closure reduces the risk for recurrent ischemic stroke in patients with a history of cryptogenic ischemic stroke. This study evaluated the cost-effectiveness of patent foramen ovale closure against medical therapy in patients after their first cryptogenic ischemic stroke in Japan.
Materials And Methods:
The cost-effectiveness of patent foramen ovale closure compared with medical therapy was evaluated using the Markov model. The target patients started with patent foramen ovale closure or medical therapy for preventing secondary ischemic stroke under a stable state. Quality-adjusted life year was used as the outcome of effectiveness, and the analysis was conducted with a discount rate of 2% applied to both cost and effectiveness. The results of a multicenter open-label randomized controlled trial (RESPECT trial) evaluating patent foramen ovale closure using the Amplatzer™ PFO Occluder were used as clinical evidence. Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio. It was evaluated as cost-effective if it was lower than 5 million JPY/ quality-adjusted life year.
Results:
Patent foramen ovale closure was dominant over medical therapy by 2.53 quality-adjusted life years and an estimated cost reduction of 2,353,926 JPY. The probability of patent foramen ovale closure being dominant was 82.9%.
Conclusions:
Patent foramen ovale closure was dominant over medical therapy for preventing secondary ischemic stroke in patients with cryptogenic ischemic stroke.
