Single centre experience with GORE-HELEX septal occluder for closure of PFO

Heart Lung Circ. 2009 Apr;18(2):140-2. doi: 10.1016/j.hlc.2007.11.141. Epub 2008 Feb 21.


Several devices are available for percutaneous patent foramen ovale (PFO) closure. Over the past 3 years our planned treatment strategy of PFO closure has been routine use of the GORE-HELEX septal occluder device, followed by 6 months of aspirin therapy. We present the safety and feasibility of routinely using this device for all patients undergoing percutaneous PFO closure, with 3-month transthoracic echocardiogram (TTE) follow up. In total, 75 adult patients (44.0+/-11.7 years; 45.3% male) were referred for PFO closure during the study period. All patients underwent echocardiography prior to PFO closure. In 5 patients no PFO was found, and 1 patient had an atrial secundum defect closed using the Amplatzer septal occluder. Of the 69 remaining patients with PFO, 68/69 (98.6%) underwent closure with the GORE-HELEX device. Six of 69 cases required device retrieval and 5 of 6 were replaced successfully with a second GORE-HELEX device. One of the 6, a large PFO associated with atrial septal aneurysm, was replaced using the Amplatzer septal occluder. There were no major complications. At 3-month follow up, 65/68 (95.6%) had no residual shunt on TTE, and 3 patients had small residual shunts thought to be related to incomplete endothelialisation at 3 months. In conclusion, percutaneous PFO closure using the GORE-HELEX septal occluder device is safe and feasible, with no major peri-procedural complications and excellent short-term results at 3-month follow up.

MeSH terms

  • Adult
  • Aspirin / administration & dosage
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods*
  • Echocardiography / methods
  • Female
  • Fibrinolytic Agents / administration & dosage
  • Follow-Up Studies
  • Foramen Ovale, Patent / diagnostic imaging
  • Foramen Ovale, Patent / therapy*
  • Humans
  • Male
  • Retrospective Studies


  • Fibrinolytic Agents
  • Aspirin