Yonsei Med J.  2016 May;57(3):621-625. 10.3349/ymj.2016.57.3.621.

Comparison of Outcomes after Device Closure and Medication Alone in Patients with Patent Foramen Ovale and Cryptogenic Stroke in Korean Population

• Moon J
• Kang WC
• Kim S
• Oh PC
• Park YM
• Chung WJ
• Choi DY
• Lee JY
• Lee YB
• Hwang HY
• Ahn T

• KMID: 2374080
• DOI: http://doi.org/10.3349/ymj.2016.57.3.621

Abstract

PURPOSE
To compare the effectiveness of device closure and medical therapy in prevention of recurrent embolic event in the Korean population with cryptogenic stroke and patent foramen ovale (PFO).
MATERIALS AND METHODS
Consecutive 164 patients (men: 126 patients, mean age: 48.1 years, closure group: 72 patients, medical group: 92 patients) were enrolled. The primary end point was a composite of death, stroke, transient ischemic attack (TIA), or peripheral embolism.
RESULTS
Baseline characteristics were similar in the two groups, except age, which was higher in the medical group (45.3±9.8 vs. 50.2±6.1, p<0.0001), and risk of paradoxical embolism score, which was higher in the closure group (6.2±1.6 vs. 5.7±1.3, p=0.026). On echocardiography, large right-to-left shunt (81.9% vs. 63.0%, p=0.009) and shunt at rest/septal hypermobility (61.1% vs. 23.9%, p<0.0001) were more common in the closure group. The device was successfully implanted in 71 (98.6%) patients. The primary end point occurred in 2 patients (2 TIA, 2.8%) in the closure group and in 2 (1 death, 1 stroke, 2.2%) in the medical group. Event-free survival rate did not differ between the two groups.
CONCLUSION
Compared to medical therapy, device closure of PFO in patients with cryptogenic stroke did not show difference in reduction of recurrent embolic events in the real world's setting. However, considering high risk of echocardiographic findings in the closure group, further investigation of the role of PFO closure in the Asian population is needed.

Keyword

Patent foramen ovale; device closure; ischemic strokes; transient ischemic attack

MeSH Terms

Adult
Aged
Aged, 80 and over
Cardiac Catheterization/adverse effects
Disease-Free Survival
Embolism/etiology/*prevention & control
Female
Fibrinolytic Agents/adverse effects/*therapeutic use
Foramen Ovale, Patent/complications/*drug therapy/mortality/*surgery
Humans
Ischemic Attack, Transient/*drug therapy/mortality/*surgery
Male
Middle Aged
Republic of Korea/epidemiology
Risk
Secondary Prevention/methods
*Septal Occluder Device/adverse effects
Stroke/etiology/prevention & control
Treatment Outcome
Fibrinolytic Agents

Figure

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  Fig. 1 Diagram for detailed enrollment of patients.

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  Fig. 2 Kaplan-Meier curves for the primary composite end point.

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