Ten years of experience with closure of persistent foramen ovale: patient characteristics and outcomes.
BACKGROUND
Optimal management of patients with persistent foramen ovale (PFO) following cryptogenic stroke or transient ischemic attack (TIA) suspected for paradoxical embolic events is still unclear. PFO closure has the potential benefit of preventing recurrent embolic events and avoiding serious bleeding resulting from long-term anticoagulation. Despite the widespread usage of closure devices, no randomized trial supports the general percutaneous closure approach. In addition, only mid-term, but not long-term, outcomes have been reported until now. The aim of the study is to assess clinical characteristics and long-term clinical outcome of patients undergoing percutaneous PFO closure.


METHODS
Included in this single-center registry trial were 146 consecutive patients who underwent percutaneous closure of PFO at the University Hospital Frankfurt from 2000 to 2009. Periprocedural outcomes and long-term events were assessed. Follow-up was available in 146 patients (100%) with a mean follow-up of 7.8±3.1 years (cumulative 1148 patient-years).


RESULTS
The cerebroischemic event leading to indicate percutaneous PFO closure was TIA (34.9%), stroke without sequels (38.4%), stroke with sequels (24.7%), amaurosis fugax (N=2; 1.4%), and peripheral emboli (N=1; 0.7%). Only one severe periprocedural complication occurred (device dislocation). The majority of patients (N=143; 97.9%) experienced no further events during follow-up.


CONCLUSIONS
This "all-comers" population documents the safety of percutaneous PFO closure. The cardiovascular event rate is slightly lower (0.26 per 100 patient years) compared to the recently published randomized trials and maintained persistently low rate for more than 8 years.
Department of Cardiology, University Hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. Electronic address: ralf.lehmann@umm.de.
Ralf
R
Lehmann
Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Stephan
S
Fichtlscherer
Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Henrica
H
Baldauf
Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Volker
V
Schächinger
Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Wolfgang
W
Auch-Schwelck
Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Andreas M
AM
Zeiher
Department of Cardiology, Johann Wolfgang Goethe-University Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Claudius
C
Teupe
D000328:Adult; D006348:Cardiac Surgical Procedures; D002986:Clinical Trials as Topic; D019320:Embolism, Paradoxical / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D054085:Foramen Ovale / Q000601:surgery*; D054092:Foramen Ovale, Patent / Q000150:complications / Q000601:surgery*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012189:Retrospective Studies; D055502:Secondary Prevention; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
Outcome; PFO closure; Stroke