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Amplatzer occluder versus CardioSEAL/STARFlex occluder: a meta-analysis of the efficacy and safety of transcatheter occlusion for patent foramen ovale and atrial septal defect

  • Yifei Li (a1) (a2), Kaiyu Zhou (a1) (a3), Yimin Hua (a1) (a3), Chuan Wang (a2), Liang Xie (a2), Jie Fang (a4), Xin Rong (a2) and Jiantong Shen (a5)...



Percutaneous transcatheter occlusion has benefited thousands of patients suffering from patent foramen ovale and atrial septal defect. However, no general agreement has been reached on the superiority among occluders. Thus, a meta-analysis between the two most commonly adopted types of occluders was conducted.


The literature review has identified relevant studies up to May, 2011 in the databases of PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and World Health Organization clinical trials registry centre. Meta-analysis was performed in a fixed/random effects model using Revman 5.1.1. Information on complications and outcomes was extracted.


Analysis from included studies reports an outcome in favour of the Amplatzer. The Amplatzer has proven its superiority in efficacy with a significantly lower risk of early (95% confidence interval = 0.09–0.34) and long-term (95% confidence interval = 0.14–0.97) residual shunt rate for atrial septal defect occlusion, although no significant difference in performance has been reported for patent foramen ovale. In addition, the Amplatzer has also remarkably reduced the risk of embolisation by the device (95% confidence interval = 0.07–0.45) for atrial septal defect and new-set atrial fibrillation (95% confidence interval = 0.18–0.48) for patent foramen ovale. On evaluation of recurrent thrombotic events, it was found that the Amplatzer greatly lowered the rate of thrombus formation on the device (95% confidence interval = 0.02–0.21) for patent foramen ovale; however, no statistical difference was found on atrial septal defect evaluation. However, the result indicated no statistically significant difference between the two kinds of occluders in stroke and transient ischaemic attack of patent foramen ovale.


The meta-analysis has proven the Amplatzer to be the superior occluder, serving better prognosis with more fluent procedure and less complications.


Corresponding author

Correspondence to: Dr K. Zhou, MD, Department of Pediatric Cardiovascular Disease, West China Second University Hospital, Sichuan University; Ministry of Education Key Laboratory of Women and Children's Diseases and Birth Defects, Chengdu, Sichuan 610041, China. Tel: +86 28 85501352; Fax: +86 28 85501059; E-mail:


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