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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

Published online by Cambridge University Press:  03 December 2012

Yifei Li
Affiliation:
Department of Pediatric Cardiovascular Disease, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China West China Medical School of Sichuan University, Chengdu, Sichuan, China
Kaiyu Zhou*
Affiliation:
Department of Pediatric Cardiovascular Disease, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China Ministry of Education Key Laboratory of Women and Children's Diseases and Birth Defects, Chengdu, Sichuan, China
Yimin Hua
Affiliation:
Department of Pediatric Cardiovascular Disease, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China Ministry of Education Key Laboratory of Women and Children's Diseases and Birth Defects, Chengdu, Sichuan, China
Chuan Wang
Affiliation:
West China Medical School of Sichuan University, Chengdu, Sichuan, China
Liang Xie
Affiliation:
West China Medical School of Sichuan University, Chengdu, Sichuan, China
Jie Fang
Affiliation:
West China Stomatology School of Sichuan University, Chengdu, Sichuan, China
Xin Rong
Affiliation:
West China Medical School of Sichuan University, Chengdu, Sichuan, China
Jiantong Shen
Affiliation:
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China
*
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: kaiyuzhou313@163.com

Abstract

Objective

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.

Methods

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.

Results

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.

Conclusion

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

Type
Original Articles
Copyright
Copyright © Cambridge University Press 2012 

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