Abstract 10319: Randomized, Controlled Trial of Transcatheter versus Surgical Closure of Perimembranous Ventricular Septal Defects in Children
Background: Perimembranous ventricular septal defect (pmVSD) is the most common form of congenital heart disease in childhood. The optimal treatment for this defect must be evaluated.
Methods and Results: From Jan 2009 to July 2010, 229 children with congenital pmVSD were randomized into a surgical or transcatheter group with matched baseline characteristics. Data from clinical records, lab exams and follow-up results from the past 2 years were compared between the groups. One major adverse event and 34 minor adverse events were observed in the surgical group while only 8 minor adverse events were recorded in the transcatheter group (p=0.006). Statistical comparisons between the surgical and transcatheter groups showed a difference (p<0.01) in the amount of blood transfusion (276.0±231.7 VS 0 mL), procedural duration (180.5± 66.1 VS 38.2±24.6 min), median hospital stay (7.2±5.7 VS 3.3±1.6 d), median ICU stay (1.2±1.7 VS 0 d), median hospitalization cost (4846.3±1628.1 VS 3550.4±745.9 $) and median blood loss (186.5±151.3 VS 54.2 ±18.9 mL). The 0-72 hours area under curve (AUC0-72) of Creatine Kinase-MB (CK-MB) and cardiac troponin I (cTnI) release of the surgical group were significantly higher than those of the transcatheter group (3415.8 VS 425.1 and 597.6 VS 4.7, respectively, p<0.01). At a median follow-up period of 2 years, both groups achieved similar results with regards to the closure rate, adverse events and complications (p>0.05).
Conclusions: Transcatheter device closure and surgical repair are both effective methods in treating pmVSD children with excellent mid-term results. Transcatheter device closure has the benefit of causing less myocardial injury, not requiring a blood transfusion, a shorter hospital stay, decreased medical expenses, and a faster recovery.
Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00890799.
- Cardiac surgery
- Ventricular septal defect
- Congenital heart disease
- Congenital heart surgery
- © 2013 by American Heart Association, Inc.