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Transcatheter Versus Surgical Closure of Perimembranous Ventricular Septal Defects in Children

医学 外科 不利影响 心脏病 随机对照试验 临床终点 房室传导阻滞 入射(几何) 临床试验 内科学 光学 物理
作者
Jian Yang,Lifang Yang,Shiqiang Yu,Jincheng Liu,Jian Zuo,Wensheng Chen,Weixun Duan,Qijun Zheng,Xuezeng Xu,Jun Li,Jun Zhang,Jian Xu,Lijun Sun,Xiuling Yang,Lize Xiong,Dinghua Yi,Lei Wang,Qingchun Liu,Shuping Ge,Jun Ren
出处
期刊:Journal of the American College of Cardiology [Elsevier BV]
卷期号:63 (12): 1159-1168 被引量:101
标识
DOI:10.1016/j.jacc.2014.01.008
摘要

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.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.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.Neither group had mortality or major complications. However, statistical analysis of the 2 groups demonstrated significant differences (p < 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 normal and there was no difference in closure rate, adverse events, and complications between groups.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; NCT00890799).

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