Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes

Eur Heart J. 2010 Sep;31(18):2238-45. doi: 10.1093/eurheartj/ehq240. Epub 2010 Aug 27.

Abstract

Aims: The aim of this study was to evaluate the safety and efficacy of transcatheter closure for perimembranous ventricular septal defect (pmVSD) and its long-term results. The most common congenital heart condition is pmVSD. Transcatheter closure of pmVSD is a recently described technique with limited results for mid- to long-term follow-up.

Methods and results: Between June 2002 and June 2008, 848 patients with pmVSD were enrolled in our study and treated percutaneously with pmVSD occluders. All patients were followed up until December 2008, an average of 37 months. According to colour Doppler transthoracic echocardiography before the intervention and ventriculography, the average end-diastolic pmVSD size was 5.1 and 5.4 mm, respectively. Placement of the device was successful in 832 patients (98.1%) and the median device size was 8.6 mm. During follow-up, 103 adverse events (12.4%) were reported. Most adverse events were categorized as minor and there were nine major adverse events (8.7%), including two complete atrioventricular block requiring pacemaker implantation. Kaplan-Meier estimates showed >85% freedom from major or minor adverse events during a maximal follow-up of 79 months.

Conclusions: In experienced hands, transcatheter pmVSD closure can be performed safely and successfully with low morbidity and mortality. Long-term prognostic results are favourable, and the transcatheter approach provides a less-invasive alternative that may become the first choice in selected pmVSD patients. This trial is registered with ClinicalTrials.gov, number NCT00890799.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Balloon Occlusion / adverse effects
  • Balloon Occlusion / instrumentation*
  • Child
  • Child, Preschool
  • Female
  • Follow-Up Studies
  • Heart Septal Defects / therapy*
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Design
  • Prosthesis Implantation / adverse effects
  • Prosthesis Implantation / methods*
  • Septal Occluder Device*
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT00890799