Off-label use of duct occluder devices to close hemodynamically significant perimembranous ventricular septal defects: A multicenter experience

Catheter Cardiovasc Interv. 2019 Jan 1;93(1):82-88. doi: 10.1002/ccd.27792. Epub 2018 Sep 12.

Abstract

Objective: We sought to evaluate the feasibility, technical aspects, and outcome of transcatheter perimembranous ventricular septal defect (pmVSD) closure using duct occluder devices with a single retention disc.

Background: Use of duct occluder devices to close pmVSD seems a promising alternative therapy. However, limited data exist on this technique.

Methods: From 2010 to 2016, 222 patients (female 47.7%) were identified from databases of five participating institutions in whom pmVSD closure was attempted using an Amplatzer Duct Occluder I or Lifetech duct occluder device.

Results: Patients ranged in age from 0.7 to 52 years (median, 7.0 years) and in weight from 4.0 to 70 kg (median, 18.0 kg). The mean size of the VSD was 6.8 ± 2.2 mm. A large defect (> 6 mm) was present in 137 patients (61.7%). Device closure was successful in 218 patients (98.2%). The 10/8 mm device was used in most patients (n = 85, 38.3%), and the vascular approach was from the femoral vein in 169 patients (76.1%). There were 18 early complications in 17/218 patients (7.8%). Three patients (1.4%) developed complete heart block (transient n = 2; requiring permanent pacing n = 1). Median follow-up was 6 months (6 months-6 years). A mild residual shunt was seen in 10 patients at 6 months follow-up.

Conclusions: The immediate results of transcatheter pmVSD closure using a duct occluder device with a single retention disc are promising. It is an effective technique with a lower rate of complications than for other currently available devices.

Keywords: closure; complete heart block; congenital heart disease; duct occluder; perimembranous ventricular septal defect.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Child
  • Child, Preschool
  • Databases, Factual
  • Egypt
  • Feasibility Studies
  • Female
  • Germany
  • Heart Septal Defects, Ventricular / diagnostic imaging
  • Heart Septal Defects, Ventricular / physiopathology
  • Heart Septal Defects, Ventricular / therapy*
  • Hemodynamics*
  • Humans
  • India
  • Infant
  • Male
  • Middle Aged
  • Practice Guidelines as Topic
  • Product Labeling*
  • Prosthesis Design
  • Retrospective Studies
  • Septal Occluder Device*
  • Treatment Outcome
  • Young Adult