Fracture of the GORE HELEX septal occluder: Associated factors and clinical outcomes

Abstract

WFF occurred in 6.4% of HELEX and were most common in large devices. With the exception of one device removed for theoretical risks, no clinical sequelae were related to WFF. WFF did not alter the function of the HELEX.

Comparison Between the New Gore Septal and Amplatzer Devices For Transcatheter Closure of Patent Foramen Ovale

“…14 We did not find any case of GSO wire frame fracture but it should be noted that fractures with the GORE HELEX Septal Occluder were mainly associated with larger devices. 15 GSO devices were easily implanted. The procedural and fluoroscopy times compare favorably with those of most commonly used devices 16 and are lower than those of the Helex device registered in our previously published series of patients 6 despite being in the "learning curve" of new device implantation.…”

Catheter closure of atrial septal defects using the Cocoon septal occluder: Preliminary results of a European multicenter study

“…Complete closure of the defect was obtained in all patients with no allergic reactions to nickel or device related complications during the procedure or at a short term follow-up. In addition, as opposed to the other currently available ASD occluders, no device deformations or fractures were observed in our patient population [16][17][18]. It appears, therefore, that CSO it is an effective and safe double disc ASD occluder that has certain design features which make it potentially attractive for catheter closure of secundum ASDs.…”

Outcomes After Transcatheter ASD Closure

“…7 Due to its non-self-centering mechanism, residual leaks are more frequently observed with the Helex device. 13,29 The vast majority, if not all, of these residual leaks seen with either device, however, are trivial or small in size (<3-4 mm) and do not result in any hemodynamic burden to the RV. Therefore, clinical cure is achieved in virtually 100% of patients.…”