title: Single centre experience with GORE-HELEX septal occluder for closure of PFO.
abstract: 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.
authors.affiliation: Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom. larryponnuthurai@googlemail.com
authors.forename: Francis A
authors.initials: FA
authors.lastname: Ponnuthurai
authors.forename: William J
authors.initials: WJ
authors.lastname: van Gaal
authors.forename: Amy
authors.initials: A
authors.lastname: Burchell
authors.forename: Andrew
authors.initials: A
authors.lastname: Mitchell
authors.forename: Neil
authors.initials: N
authors.lastname: Wilson
authors.forename: Oliver
authors.initials: O
authors.lastname: Ormerod
mesh_terms: D000328:Adult; D001241:Aspirin / Q000008:administration & dosage; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods*; D004452:Echocardiography / Q000379:methods; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D012189:Retrospective Studies
chemical_list: D005343:Fibrinolytic Agents; D001241:Aspirin