Case Report
Single Centre Experience with GORE-HELEX Septal Occluder for Closure of PFO

https://doi.org/10.1016/j.hlc.2007.11.141Get rights and content

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.

Introduction

There are several approved devices for percutaneous patent foramen ovale (PFO) closure.1, 2 Since November 2003, our planned treatment strategy of PFO closure has been routine use of the GORE-HELEX septal occluder device (GORE, Flagstaff, AZ, USA), followed by 6 months of aspirin therapy. The use of this device has been reported to be more difficult and associated with a greater learning curve compared with other currently available devices.3 The GORE-HELEX device has a sheathless delivery system and an intrinsic retrieval system. In our experience the low-profile nature favours a more axial alignment with the septum and conforms to the length of the PFO tunnel. We present the safety and feasibility of using this device for all adult patients undergoing percutaneous PFO closure, with 3-month transthoracic echocardiogram (TTE) follow up.

Section snippets

Methods

This study was a single centre, retrospective cohort study of all patients referred for percutaneous PFO closure at the John Radcliffe Hospital in Oxford between 1st January 2004 and 31st December 2006. Patients were identified from the cardiac catheterisation laboratory database, and the medical records of all patients were reviewed. All devices were deployed by one of three operators under transoesophageal (TOE), transthoracic (TTE) or intracardiac echocardiography (ICE) guidance. During the

Results

In total, 75 adult patients were referred for PFO closure during the study period. There were 34 males (45.3%), and the mean age of patients was 44.0 ± 11.7 years. Referral indications were stroke or TIA (n = 53), peripheral embolism (n = 9), decompression sickness (n = 9) and severe migraine (n = 4).

All patients had ultrasound guided PFO closure, with ICE in 64, TOE in 10 and TTE in one patient. Atrial septal aneurysms were present in 16/75 (21.3%). At the time of procedural echocardiography, no PFO was

Discussion

To our knowledge this is the largest published single centre experience of adult PFO closure with the GORE-HELEX septal occluder. Our study demonstrates that a planned treatment strategy of PFO closure with routine use of the GORE-HELEX septal occluder device for all patients is safe, feasible and associated with a high rate of procedural success.

The structure of the HELEX occluder is designed to conform to the contours of the septum without bulky protrusion into the atria. It is composed of a

References (5)

  • E. Onorato et al.

    Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients

    J Interv Cardiol

    (2003)
  • M. Braun et al.

    Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism. Periprocedural safety and mid-term follow-up results of three different device occluder systems

    Eur Heart J

    (2004)
There are more references available in the full text version of this article.
View full text