Related Experiment Video
Updated: Sep 21, 2025

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Cost-effectiveness analysis of patent foramen ovale closure versus medical therapy alone after cryptogenic stroke
Yoko Shijoh1, Shota Saito2, Zhehao Dai3,4
1Graduate School of Public Health St. Luke's International University, Chuo-City, Tokyo, Japan.
Insights
Patent foramen ovale closure is a cost-effective treatment for cryptogenic stroke in young Japanese patients. This intervention offers a favorable incremental cost-effectiveness ratio compared to medical therapy alone.
Area of Science:
- Cardiovascular Medicine
- Health Economics
- Neurology
Background:
- Patent foramen ovale closure reduces recurrent stroke risk in young patients with cryptogenic strokes.
- Previous cost-effectiveness analyses outside Japan suggest PFO closure is cost-effective.
- No studies have evaluated the cost-effectiveness of PFO closure in Japan.
Purpose of the Study:
- To assess the cost-effectiveness of patent foramen ovale (PFO) closure versus medical therapy alone for Japanese patients with cryptogenic strokes.
- To evaluate the economic impact from a Japanese healthcare payer's perspective.
- To determine if PFO closure is a viable treatment option within Japan's healthcare system.
Main Methods:
- A cost-effectiveness study using a decision tree and Markov model.
- Utilized data from the RESPECT study for probabilities and a 5.9-year time horizon.
- Assessed costs and utilities from published studies and expert opinions, with a willingness-to-pay threshold of $50,000/QALY.
Main Results:
- The incremental cost-effectiveness ratio (ICER) was $29,208 per quality-adjusted life year (QALY) gained.
- Patent foramen ovale closure was found to be cost-effective at a stable state utility score difference >0.051.
- Probabilistic sensitivity analyses indicated a 50.3% probability of PFO closure being cost-effective.
Conclusions:
- Patent foramen ovale closure is a cost-effective strategy compared to medical therapy alone for Japanese patients.
- The study population included patients with cryptogenic stroke and PFO, aged 60 years or younger.
- Findings support the consideration of PFO closure for eligible patients in Japan.
Background:
Closure of a patent foramen ovale reduces the risk of recurrent stroke compared with medical therapy alone in young patients with cryptogenic strokes revealed by randomized control trials. Some cost-effectiveness analyses outside Japan have shown that patent foramen ovale closure is cost-effective, but no studies have examined cost-effectiveness in Japan. The objective of this study is to assess cost-effectiveness, from the perspective of a Japanese healthcare payer, of patent foramen ovale closure versus medical therapy alone for patients with patent foramen ovale related to cryptogenic strokes.
Methods:
A cost-effectiveness study was conducted by developing a decision tree and a Markov model. Probabilities and a 5.9-year time horizon followed the RESPECT study. Utilities and costs were based upon published studies and assumptions. All assumptions were assessed by experts, including a cardiologist and a statistical expert. The target population comprised patients with cryptogenic stroke and patent foramen ovale, aged 60 years or younger. The model was discounted at 2.0% and its cycle was one month. A willingness-to-pay threshold is set at $50,000 / quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio was evaluated. Then one-way sensitivity analyses as deterministic sensitivity analysis, and probabilistic sensitivity analyses were performed to assess data robustness.
Results:
Incremental quality-adjusted life years, incremental costs, and incremental cost-effectiveness ratio were 0.464, $13,562, and $29,208 per QALY gained, respectively. One-way sensitivity analysis showed that the stable state utility score difference between patent foramen ovale closure and medical therapy had the largest impact on incremental cost-effectiveness ratio. Patent foramen ovale closure is cost-effective at a stable state utility score difference of >0.051, compared with medical therapy. Probabilistic sensitivity analyses demonstrated that patent foramen ovale closure was 50.3% cost-effective.
Conclusions:
Patent foramen ovale closure was cost-effective compared with medical therapy for Japanese patients with cryptogenic stroke who were ≤60 years.
Related Concept Videos
Mitral Stenosis III: Medical Management
Mitral Regurgitation III: Medical Management
Aortic Regurgitation III: Medical Management

