Cost Effectiveness of Percutaneous Closure Versus Medical Therapy for Cryptogenic Stroke in Patients With a Patent Foramen Ovale

2014 ◽  
Vol 114 (10) ◽  
pp. 1584-1589 ◽  
Author(s):  
Christopher A. Pickett ◽  
Todd C. Villines ◽  
Michael A. Ferguson ◽  
Edward A. Hulten
2021 ◽  
Author(s):  
Yoko Shijoh ◽  
Shota Saito ◽  
Zhehao Dai ◽  
Sachiko Ohde

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 the patients with patent foramen ovale related 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. The model cycle was one month. 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. Incremental cost-effectiveness ratio was evaluated. Then one-way sensitivity analyses and probabilistic sensitivity analyses were conducted to assess robustness. Results Incremental cost-effectiveness ratio of patent foramen ovale closure compared with medical therapy was estimated at 3,318,152 yen per quality-adjusted life years gained. 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 with a willingness-to-pay threshold of 5,000,000 yen / quality-adjusted life years. Conclusions From a healthcare payer perspective, patent foramen ovale closure may be cost-effective compared with medical therapy for Japanese patients with cryptogenic stroke who were under 60 years.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
N Paredes Hurtado ◽  
M Delgado Ortega ◽  
A Rodriguez Almodovar ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine  clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p <0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.


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