Comparison of Outcomes after Device Closure and Medication Alone in Patients with Patent Foramen Ovale and Cryptogenic Stroke in Korean Population.
10.3349/ymj.2016.57.3.621
- Author:
Jeonggeun MOON
1
;
Woong Chol KANG
;
Sihoon KIM
;
Pyung Chun OH
;
Yae Min PARK
;
Wook Jin CHUNG
;
Deok Young CHOI
;
Ji Yeon LEE
;
Yeong Bae LEE
;
Hee Young HWANG
;
Taehoon AHN
Author Information
1. Cardiology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Korea. kangwch@gilhospital.com
- Publication Type:Comparative Study ; Original Article
- Keywords:
Patent foramen ovale;
device closure;
ischemic strokes;
transient ischemic attack
- MeSH:
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
- From:Yonsei Medical Journal
2016;57(3):621-625
- CountryRepublic of Korea
- Language:English
-
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.
