title: Long term follow up after percutaneous closure of PFO in 357 patients with paradoxical embolism: Difference in occlusion systems and influence of atrial septum aneurysm.
abstract: BACKGROUND
  Percutaneous transcatheter closure of patent foramen ovale (PFO) in cryptogenic stroke or TIA is an alternative to medical therapy especially in patients with atrial septal aneurysm (ASA). The differences in time to complete occlusion for various closure devices in PFO alone and PFO plus ASA are of natural interest.
  
  
  RESULTS
  Between January, 1st 1998 and November, 30th 2006 percutaneous PFO closure was performed in 357 patients with a history of > or =1 paradoxical embolism using three different devices: Amplatzer PFO-(n=199), Starflex-(n=48) and Helex Occluder (n=110). All patients were assigned to a post-interventional protocol with contrast-enhanced transesophageal echocardiography (TOE) at 1 and 6 months and every 6 to 12 months in case of incomplete closure. Definite closure was confirmed in at least two consecutive TOE studies. The closure time curves between the three devices were significantly different (p=0.0072). Devices of 25 mm or less had a better occlusion rate. The difference between the closure time curves of PFO and PFO+ASA concerning each device type was significant for Helex (p=0.006) and Starflex (p=0.030). In regard to the occlusion time for large devices Helex succeeded later than Amplatzer and Starflex (p=0.0029). Concerning the cumulative follow up period of 1265 patient years the recurrence/re-event rate of cerebral and peripheral thromboembolic events was 0.7% per patient year. No relation to residual PFO shunting or to thrombus formation was seen. There were no peri-interventional technical complications. In five patients of the Starflex group thrombi were detected in the four week TOE controls.
  
  
  CONCLUSIONS
  The closure rate is dependent on occluder size and type plus the occurrence of an atrial septum aneurysm.
authors: 2nd Medical Clinic, Johannes Gutenberg-University Mainz, Germany.
authors: Ralph Stephan
authors: RS
authors: von Bardeleben
authors: Claudia
authors: C
authors: Richter
authors: Julia
authors: J
authors: Otto
authors: Ludmilla
authors: L
authors: Himmrich
authors: Renate
authors: R
authors: Schnabel
authors: Christoph
authors: C
authors: Kampmann
authors: Hans-Jürgen
authors: HJ
authors: Rupprecht
authors: Jürgen
authors: J
authors: Marx
authors: Gerhard
authors: G
authors: Hommel
authors: Thomas
authors: T
authors: Münzel
authors: Georg
authors: G
authors: Horstick
mesh_terms: D000328:Adult; D000368:Aged; D004452:Echocardiography; D019320:Embolism, Paradoxical / Q000000981:diagnostic imaging / Q000209:etiology* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications* / Q000000981:diagnostic imaging / Q000601:surgery*; D006322:Heart Aneurysm / Q000150:complications* / Q000000981:diagnostic imaging / Q000601:surgery*; D006346:Heart Septum; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000000981:diagnostic imaging; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000379:methods; D016896:Treatment Outcome