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Transcatheter versus surgical closure of perimembranous ventricular septal defects in children: a randomized controlled trial.

Abstract：

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 < 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. 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; NCT00890799).

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Yang J,Yang L,Yu S,Liu J,Zuo J,Chen W,Duan W,Zheng Q,Xu X,Li J,Zhang J,Xu J,Sun L,Yang X,Xiong L,Yi D,Wang L,Liu Q,Ge S,Ren J

doi

10.1016/j.jacc.2014.01.008

subject

Has Abstract

pub_date

2014-04-01 00:00:00

pages

1159-1168

issue

eissn

0735-1097

issn

1558-3597

pii

S0735-1097(14)00292-7

journal_volume

pub_type

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Transcatheter versus surgical closure of perimembranous ventricular septal defects in children: a randomized controlled trial.