Author + information
- Received June 25, 2013
- Revision received December 28, 2013
- Accepted January 6, 2014
- Published online April 1, 2014.
- Jian Yang, MD, PhD∗∗ (, )
- Lifang Yang, MD∗,
- Shiqiang Yu, MD, PhD∗,
- Jincheng Liu, MD, PhD∗,
- Jian Zuo, MD∗,
- Wensheng Chen, MD, PhD∗,
- Weixun Duan, MD∗,
- Qijun Zheng, MD∗,
- Xuezeng Xu, MD∗,
- Jun Li, MD∗,
- Jun Zhang, MD, PhD∗,
- Jian Xu, MD∗,
- Lijun Sun, MD, PhD∗,
- Xiuling Yang, MD∗,
- Lize Xiong, MD, PhD∗,
- Dinghua Yi, MD, PhD∗∗,
- Lei Wang, MD†,
- Qingchun Liu, MD‡,
- Shuping Ge, MD∗,§∗ and
- Jun Ren, MD, PhD∗,‖
- ∗Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China
- †Department of Cardiology, Xi'an Children Hospital, Xi'an, China
- ‡Department of Cardiovascular Surgery, Hanzhong Central Hospital, Hanzhong, China
- §Heart Center at St. Christopher's Hospital for Children and Drexel University College of Medicine, Philadelphia, Pennsylvania
- ‖College of Health Sciences, University of Wyoming, Laramie, Wyoming
- ↵∗Reprint requests and correspondence:
Drs. Jian Yang, Dinghua Yi, or Shuping Ge, Xijing Cardiovascular Hospital, Xi'an, China, 710032.
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)
This trial was supported by funding from the National Natural Science Foundation of China (grants 30900462 and 81170213). All authors have reported that they have no relationships relevant to the contents of this paper to disclose. The first 5 authors contributed equally to this paper.
- Received June 25, 2013.
- Revision received December 28, 2013.
- Accepted January 6, 2014.
- 2014 American College of Cardiology Foundation