title: Transcatheter versus surgical closure of perimembranous ventricular septal defects in children: a randomized controlled trial.
abstract: OBJECTIVE
  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).
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China. Electronic address: yangjian1212@hotmail.com.
authors: Jian
authors: J
authors: Yang
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Lifang
authors: L
authors: Yang
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Shiqiang
authors: S
authors: Yu
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Jincheng
authors: J
authors: Liu
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Jian
authors: J
authors: Zuo
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Wensheng
authors: W
authors: Chen
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Weixun
authors: W
authors: Duan
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Qijun
authors: Q
authors: Zheng
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Xuezeng
authors: X
authors: Xu
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Jun
authors: J
authors: Li
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Jun
authors: J
authors: Zhang
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Jian
authors: J
authors: Xu
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Lijun
authors: L
authors: Sun
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Xiuling
authors: X
authors: Yang
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Lize
authors: L
authors: Xiong
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors: Dinghua
authors: D
authors: Yi
authors: Department of Cardiology, Xi'an Children Hospital, Xi'an, China.
authors: Lei
authors: L
authors: Wang
authors: Department of Cardiovascular Surgery, Hanzhong Central Hospital, Hanzhong, China.
authors: Qingchun
authors: Q
authors: Liu
authors: 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.
authors: Shuping
authors: S
authors: Ge
authors: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China; College of Health Sciences, University of Wyoming, Laramie, Wyoming.
authors: Jun
authors: J
authors: Ren
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D016063:Blood Loss, Surgical; D001803:Blood Transfusion / Q000706:statistics & numerical data; D001806:Blood Urea Nitrogen; D006328:Cardiac Catheterization; D002315:Cardiopulmonary Bypass; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000097:blood; D018618:Echocardiography, Doppler, Color; D018619:Echocardiography, Doppler, Pulsed; D005260:Female; D006345:Heart Septal Defects, Ventricular / Q000000981:diagnostic imaging / Q000601:surgery*; D006352:Heart Ventricles / Q000000981:diagnostic imaging; D006760:Hospitalization / Q000191:economics; D006801:Humans; D015278:Intensive Care Units, Pediatric; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D011183:Postoperative Complications; D011446:Prospective Studies; D055989:Septal Occluder Device; D019210:Troponin I / Q000097:blood; D054088:Ventricular Septum / Q000000981:diagnostic imaging
chemical_list: D019210:Troponin I; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: mortality; randomized controlled trial; surgery; transcatheter; ventricular septal defect