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J Am Coll Cardiol. 2014 Apr 1;63(12):1159-1168. doi: 10.1016/j.jacc.2014.01.008. Epub 2014 Feb 5.

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

Author information

1
Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China. Electronic address: yangjian1212@hotmail.com.
2
Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
3
Department of Cardiology, Xi'an Children Hospital, Xi'an, China.
4
Department of Cardiovascular Surgery, Hanzhong Central Hospital, Hanzhong, China.
5
Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Heart Center at St. Christopher's Hospital for Children and Drexel University College of Medicine, Philadelphia, Pennsylvania.
6
Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China; College of Health Sciences, University of Wyoming, Laramie, Wyoming.

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).

KEYWORDS:

mortality; randomized controlled trial; surgery; transcatheter; ventricular septal defect

PMID:
24509270
DOI:
10.1016/j.jacc.2014.01.008
[Indexed for MEDLINE]
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