Transcatheter Versus Surgical Closure of Perimembranous Ventricular Septal Defects in Children: A Randomized Controlled Trial

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• 作者：Jian Yang ; MD ; PhD^&lowast ; ; ^{yangjian1212@hotmail.com" class="auth_mail} ; Lifang Yang ; MD^&lowast ; ; Shiqiang Yu ; MD ; PhD^&lowast ; ; Jincheng Liu ; MD ; PhD^&lowast ; ; Jian Zuo ; MD^&lowast ; ; Wensheng Chen ; MD ; PhD^&lowast ; ; Weixun Duan ; MD^&lowast ; ; Qijun Zheng ; MD^&lowast ; ; Xuezeng Xu ; MD^&lowast ; ; Jun Li ; MD^&lowast ; ; Jun Zhang ; MD ; PhD^&lowast ; ; Jian Xu ; MD^&lowast ; ; Lijun Sun ; MD ; PhD^&lowast ; ; Xiuling Yang ; MD^&lowast ; ; Lize Xiong ; MD ; PhD^&lowast ; ; Dinghua Yi ; MD ; PhD^&lowast ; ; ; Lei Wang ; MD^&dagger ; ; Qingchun Liu ; MD^&Dagger ; ; Shuping Ge ; MD^&lowast ; ; ^§ ; ; ; Jun Ren ; MD ; PhD^&lowast ; ; ^鈥?/sup>
• 关键词：mortality ; randomized controlled trial ; surgery ; transcatheter ; ventricular septal defect
• 刊名：Journal of the American College of Cardiology
• 出版年：1 April, 2014
• 年：2014
• 卷：63
• 期：12
• 页码：1159-1168
• 全文大小：1751 K

文摘

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Objectives

The objective of this study was to evaluate the safety and efficacy of the surgical versus transcatheter approach to correct perimembranous ventricular septal defects (pmVSDs) in a prospective, randomized, controlled clinical trial.

Background

pmVSD is a common congenital heart disease in children. Surgical closure of pmVSD is a well-established therapy but requires open-heart surgery with cardiopulmonary bypass. Although the transcatheter approach is associated with significant incidence of complete atrioventricular block, it may provide a less invasive alternative. Critical comparison of the safety and efficacy of the 2 interventions necessitates a prospective, randomized, controlled trial.

Methods

Between January 2009 and July 2010, 229 children with pmVSD were randomly assigned to surgical or transcatheter intervention. Clinical, laboratory, procedural, and follow-up data over a 2-year period were compared.

Results

Neither group had mortality or major complications. However, statistical analysis of the 2 groups demonstrated significant differences (p聽< 0.001) in minor adverse events (32 vs. 7), quantity of blood transfused, duration of the procedure, median hospital stay, median intensive care unit stay, median hospitalization cost, and median blood loss. During a median follow-up of 2 years, the left ventricular end-diastolic dimension of both groups returned to聽normal and there was no difference in closure rate, adverse events, and complications between groups.

Conclusions

Transcatheter device closure and surgical repair are effective interventions with excellent midterm results for treating pmVSD in children. Transcatheter device closure has a lower incidence of myocardial injury, less blood transfused, faster recovery, shorter hospital stay, and lower medical expenses. (Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects; )