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Related Experiment Videos

First experience with the 2005 modified Gore Helex ASD occluder system.

R Kozlik-Feldmann1, R Dalla Pozza, U Römer

  • 1Department of Pediatric, Klinikum Grosshadern, Ludwig-Maximilians-University Munich, 81366 Munich, Germany. kozlik-f@lrz.uni-muenchen.de

Clinical Research in Cardiology : Official Journal of the German Cardiac Society
|July 18, 2006
PubMed
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The modified Helex device successfully closed atrial septal defects (ASD) and persistent foramen ovale (PFO) in 11 patients. This minimally invasive procedure showed a 91% immediate occlusion rate with good device adaptation and low complication risk.

Area of Science:

  • Cardiovascular Medicine
  • Medical Devices
  • Interventional Cardiology

Background:

  • Atrial septal defects (ASD) and persistent foramen ovale (PFO) are common cardiac conditions.
  • Transcatheter device closure has become a standard treatment for these defects.
  • The Helex device, modified in 2005, aimed to simplify implantation for ASD and PFO closure.

Purpose of the Study:

  • To evaluate the initial clinical experience with the modified Helex device for ASD and PFO closure.
  • To assess the safety and efficacy of the Helex device in a pediatric and adult population.
  • To report on implantation success rates, procedural times, and early occlusion outcomes.

Main Methods:

  • Retrospective analysis of 11 patients (8 children, 3 adults) who underwent implantation of the modified Helex device.

Related Experiment Videos

  • Patients were treated for relevant ASD with significant left-to-right shunts or PFO with a history of embolic events.
  • Device implantation was performed percutaneously, with procedural success and early occlusion rates assessed.

    • Main Results:

    • Successful implantation of the Helex occluder in all 11 patients.
    • Mean fluoroscopy time was 8.4 minutes.
    • Immediate occlusion rate after 24 hours was 91%, with excellent device adaptation to cardiac structures.

    Conclusions:

    • The modified Helex occluder is a reliable device for the transcatheter closure of small to moderate ASDs and PFOs.
    • The simplified delivery system facilitates implantation.
    • The procedure demonstrated a minimal risk of major complications in this initial series.