Jian Yang1, Lifang Yang2, Shiqiang Yu2, Jincheng Liu2, Jian Zuo2, Wensheng Chen2, Weixun Duan2, Qijun Zheng2, Xuezeng Xu2, Jun Li2, Jun Zhang2, Jian Xu2, Lijun Sun2, Xiuling Yang2, Lize Xiong2, Dinghua Yi2, Lei Wang3, Qingchun Liu4, Shuping Ge5, Jun Ren6. 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 pmVSDin 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).
RCT Entities:
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).
Authors: Nikolaus A Haas; Laura Kock; Harald Bertram; Regina Boekenkamp; Daniel De Wolf; Igor Ditkivskyy; Matthias W Freund; Marc Gewillig; Christoph M Happel; Ulrike Herberg; Edvard Karthasyan; Rainer Kozlik-Feldmann; Oliver Kretschmar; Yulia Kuzmenko; Ornella Milanesi; Goetz Mueller; Giacomo Pongiglione; Stephan Schubert; Gleb Tarusinov; Christoph Kampmann Journal: Pediatr Cardiol Date: 2016-11-15 Impact factor: 1.655